Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2, 3
 Well-established use                                             Traditional use

                                                                  With regard to the registration application of
                                                                  Article 16d(1) of Directive 2001/83/EC

                                                                  Pistacia lentiscus L., resina (mastic)

                                                                  i) Herbal substance

                                                                  Not applicable

                                                                  ii) Herbal preparations

                                                                  Powdered herbal substance



3. Pharmaceutical form
 Well-established use                                             Traditional use

                                                                  Powdered herbal substance in solid dosage form
                                                                  for oral use.

                                                                  Powdered herbal substance in semi-solid dosage
                                                                  form for cutaneous use.

                                                                  The pharmaceutical form should be described by
                                                                  the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                             Traditional use

                                                                  Indication 1)

                                                                  Traditional herbal medicinal product used in mild
                                                                  dyspeptic disorders.

                                                                  Indication 2)

                                                                  Traditional herbal medicinal product used for the

2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
3 The material complies with the Ph. Eur. monograph (ref.: 1876)




European Union herbal monograph on Pistacia lentiscus L., resina (mastic)
EMA/HMPC/46758/2015                                                                                                  Page 2/6
 Well-established use                                             Traditional use

                                                                  symptomatic treatment of minor inflammations
                                                                  of the skin and as an aid in healing of minor
                                                                  wounds.

                                                                  The product is a traditional herbal medicinal
                                                                  product for use in the specified indications
                                                                  exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                             Traditional use

                                                                  Posology

                                                                  Indication 1)

                                                                  Adults and elderly

                                                                  Single dose: 0.5-1 g 2 times daily

                                                                  Daily dose: 1-2 g

                                                                  The use in children and adolescents under 18
                                                                  years of age is not recommended (see section
                                                                  4.4 ‘Special warnings and precautions for use’).

                                                                  Indication 2)

                                                                  Adolescents, adults and elderly

                                                                  Semi-solid preparations containing 9-11% of the
                                                                  powdered herbal substance to be applied as a
                                                                  thin layer on the affected area up to 3 times
                                                                  daily.

                                                                  The use in children under 12 years of age is not
                                                                  recommended (see section 4.4 ‘Special warnings
                                                                  and precautions for use’).

                                                                  Duration of use

                                                                  Indication 1)

                                                                  If the symptoms persist longer than 2 weeks
                                                                  during the use of the medicinal product, a doctor
                                                                  or a qualified health care practitioner should be
                                                                  consulted.

                                                                  Indication 2)

                                                                  If the symptoms persist longer than 1 week
                                                                  during the use of the medicinal product, a doctor
                                                                  or a qualified health care practitioner should be
                                                                  consulted.




European Union herbal monograph on Pistacia lentiscus L., resina (mastic)
EMA/HMPC/46758/2015                                                                                              Page 3/6
 Well-established use                                             Traditional use

                                                                  Method of administration

                                                                  Indication 1)

                                                                  Oral use

                                                                  Indication 2)

                                                                  Cutaneous use

Contraindications

4.3. Contraindications

 Well-established use                                             Traditional use

                                                                  Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                             Traditional use

                                                                  Indication 1)

                                                                  The use in children and adolescents under 18
                                                                  years of age has not been established due to
                                                                  lack of adequate data.

                                                                  Indication 2)

                                                                  The use in children under 12 years of age has
                                                                  not been established due to lack of adequate
                                                                  data.

                                                                  If signs of skin infection are observed, a doctor
                                                                  or a qualified health care practitioner should be
                                                                  consulted.

                                                                  If the symptoms worsen during the use of the
                                                                  medicinal product, a doctor or a qualified health
                                                                  care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                             Traditional use

                                                                  None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                             Traditional use

                                                                  None known

                                                                  If adverse reactions occur, a doctor or a
                                                                  qualified health care practitioner should be
                                                                  consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
Well-established use                                             Traditional use

                                                                 With regard to the registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC as
                                                                 amended

                                                                 Ilex paraguariensis St. Hilaire, folium (maté) 3

                                                                 i) Herbal substance

                                                                    Not applicable.

                                                                 ii) Herbal preparations

                                                                    Comminuted herbal substance



3. Pharmaceutical form
Well-established use                                             Traditional use

                                                                 Comminuted herbal substance as herbal tea for
                                                                 oral use.

                                                                 The pharmaceutical form should be described by
                                                                 the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                             Traditional use

                                                                 Indication 1)

                                                                 Traditional herbal medicinal product for symptoms
                                                                 of fatigue and sensation of weakness.

                                                                 Indication 2)

                                                                 Traditional herbal medicinal product to increase
                                                                 the amount of urine to achieve flushing of the

1 The material complies with DAC 2004 M- 066 and with Pharmacopée française, 10ème édition MATE VERT, janvier 1994.
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3 The content of polycyclic aromatic hydrocarbons (PAH) should be adequately controlled.

Community herbal monograph on Ilex paraguariensis St. Hilaire, folium
EMA/HMPC/580539/2008                                                                                                 Page 2/6
Well-established use                                             Traditional use

                                                                 urinary tract as an adjuvant in minor urinary
                                                                 complaints.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in specified indications exclusively
                                                                 based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                             Traditional use

                                                                 Posology

                                                                 Adults

                                                                 Indication 1)

                                                                 Daily dose:
                                                                 Comminuted herbal substance as herbal tea:
                                                                 2-4 g corresponding to 1 g herbal substance
                                                                 3 times per day.

                                                                 Indication 2)

                                                                 Daily dose:
                                                                 Comminuted herbal substance as herbal tea:
                                                                 2.5-5 g corresponding to 2.5 g herbal substance
                                                                 1 to 2 times per day.

                                                                 The use in children and adolescents under 18
                                                                 years of age is not recommended (see section 4.4
                                                                 ‘Special warning and precautions for use’).

                                                                 Duration of use

                                                                 Indication 1)

                                                                 If the symptoms persist longer than 1 week
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Indication 2)

                                                                 If the symptoms persist longer than 2 weeks
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Method of administration

                                                                 Oral use.




Community herbal monograph on Ilex paraguariensis St. Hilaire, folium
EMA/HMPC/580539/2008                                                                                           Page 3/6

Contraindications

4.3. Contraindications

Well-established use                                             Traditional use

                                                                 Hypersensitivity to the active substance(s).

                                                                 Gastric and duodenal ulcers, cardiovascular
                                                                 disorders such as hypertension and arrhythmia,
                                                                 hyperthyroidism.

                                                                 Conditions where a reduced fluid intake is
                                                                 recommended, e.g. obstruction of the urinary
                                                                 tract.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                             Traditional use

                                                                 Indications 1) and 2)

                                                                 The use in children and adolescents under
                                                                 18 years of age is not recommended due to lack
                                                                 of adequate data.

                                                                 Not recommended before bedtime as it may cause
                                                                 sleep disturbances.

                                                                 Indication 2)

                                                                 If complaints or symptoms such as fever, dysuria,
                                                                 spasms or blood in urine occur during the use of
                                                                 the medicinal product, a doctor or a qualified
                                                                 health care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                             Traditional use

                                                                 Persons taking MAO-inhibitor drugs should use
                                                                 mate with caution.

                                                                 Caffeine containing preparations reduce sedative
                                                                 action and increase side effects caused by
                                                                 sympathomimetic drugs.

Undesirable effects

4.8. Undesirable effects

Well-established use                                             Traditional use

                                                                 None known.

                                                                 If adverse reactions occur, a doctor or a qualified
                                                                 health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
 Well-established use                                            Traditional use

                                                                 With regard to the registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC as
                                                                 amended

                                                                 Matricaria recutita L., aetheroleum (matricaria
                                                                 oil)

                                                                 i) Herbal substance

                                                                 Not applicable.

                                                                 ii) Herbal preparation

                                                                 Essential oil



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal preparations in liquid dosage forms for
                                                                 use as a bath additive.

                                                                 The pharmaceutical form should be described by
                                                                 the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

                                                                 Traditional herbal medicinal product used for
                                                                 adjuvant therapy of irritations of skin and
                                                                 mucosae in the anal and genital region, after
                                                                 serious conditions have been excluded by a
                                                                 medical doctor.

                                                                 The product is a traditional herbal medicinal

1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the Ph. Eur. monograph (ref.: 1836).


European Union herbal monograph on Matricaria recutita L., aetheroleum
EMA/HMPC/278814/2010                                                                                                 Page 2/5
 Well-established use                                            Traditional use

                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                            Traditional use

                                                                 Posology

                                                                 Adolescents, adults and elderly

                                                                 Single dose

                                                                 Use as bath additive: 0.5 – 1 mg per litre
                                                                 Full bath: approximately 100 litre
                                                                 Partial bath: 20 – 50 litre

                                                                 Average daily dose

                                                                 Full bath: one bath per day or every other day
                                                                 Partial bath: one or two times per day

                                                                 The use in children under 12 years of age is not
                                                                 recommended (see section 4.4 ‘Special warnings
                                                                 and precautions for use’).

                                                                 Duration of use

                                                                 Duration of bath: 10 – 20 minutes

                                                                 If the symptoms persist longer than one week
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Method of administration

                                                                 Cutaneous use.

                                                                 Use as bath additive. Recommended temperature
                                                                 of bath: 35 – 38 °C

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance and to
                                                                other plants of the Asteraceae (Compositae)
                                                                family.

                                                                Full baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever, severe infections, severe circulatory
                                                                disturbances and cardiac insufficency.



European Union herbal monograph on Matricaria recutita L., aetheroleum
EMA/HMPC/278814/2010                                                                                           Page 3/5
 Well-established use                                           Traditional use

                                                                Partial baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever and severe infections.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 The use in children under 12 years of age has not
                                                                 been established due to lack of adequate data.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                            Traditional use

                                                                 None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 Hypersensitivity reactions including severe
                                                                 allergic reaction (dyspnoea, Quincke’s disease,
                                                                 vascular collapse, anaphylactic shock) following
                                                                 mucosal contact with liquid chamomile
                                                                 preparations have been reported. The frequency
                                                                 is not known.

                                                                 If other adverse reactions not mentioned above


European Union herbal monograph on Matricaria recutita L., aetheroleum
EMA/HMPC/278814/2010                                                                                           Page 4/5
 Well-established use                                            Traditional use

                                                                 occur, a doctor or a qualified health care
                                                                 practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
 Well-established use                                             Traditional use

                                                                  With regard to the registration application of Article
                                                                  16d(1) of Directive 2001/83/EC as amended
                                                                  Matricaria recutita L., flos (matricaria flower)
                                                                  i) Herbal substance

                                                                  As defined in the Ph. Eur. monograph.
                                                                  ii) Herbal preparations

                                                                  a)   Comminuted herbal substance
                                                                  b)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 96% V/V:water:ammonia solution
                                                                       10% m/m (50:47.5:2.5) 3
                                                                  c)   Liquid extract (DER 1:4.3-5.7), extraction
                                                                       solvent: ethanol 96% V/V:water:ammonia
                                                                       solution 10% m/m (50:47.5:2.5)3

                                                                  d)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 48% V/V:ammonia solution 10% m/m
                                                                       (39:1)3

                                                                  e)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 45% V/V:ammonia solution 10% m/m
                                                                       (14.7:1)
                                                                  f)   Dry extract (DER 4-7:1), extraction solvent:
                                                                       ethanol 50% m/m
                                                                  g)   Liquid extract (DER 1:1.7-2.6), extraction
                                                                       solvent: ethanol 48% V/V

                                                                  h)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 55% V/V
                                                                  i)   Liquid extract (DER 1:2), extraction solvent:
                                                                       ethanol 70% V/V

                                                                  j)   Liquid extract (DER 1:4.1-4.6), extraction
                                                                       solvent: ethanol 55% V/V:Poloxamer 188
                                                                       (993:3)

                                                                  k)   Liquid extract (DER 1:1.8-2.1), extraction
                                                                       solvent: ethanol 52% V/V:macrogol
                                                                       hydroxystearate (99.5:0.5)

1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the Ph. Eur. monograph (ref.: 0404).
3
  The material complies with the Ph. Eur. monograph (ref.: 1544).


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                                 Page 2/13
 Well-established use                                             Traditional use

                                                                  l)   Liquid extract (DER 1:4-4.5) extraction
                                                                       solvent: ethanol 38.5% m/m (containing
                                                                       1.36% sodium acetate trihydrate, 0.45%
                                                                       sodium ascorbate and 0.41% sodium
                                                                       hydroxide)
                                                                  m) Liquid extract (DER 2.7-5.5:1), extraction
                                                                     solvent: ethanol 95.4% V/V (containing
                                                                     0.22% sodium acetate, 0.12% sodium
                                                                     hydroxide)
                                                                  n)   Dry extract (DER 11-16:1), extraction solvent:
                                                                       ethanol 95.4% V/V (containing 0.22% sodium
                                                                       acetate, 0.12% sodium hydroxide)
                                                                  o)   Liquid extract (DER 1:2-2.8), extraction
                                                                       solvent: propan-2-ol 48% V/V



3. Pharmaceutical form
 Well-established use                                             Traditional use

                                                                  Herbal substance or comminuted herbal substance
                                                                  as herbal tea for oral use and inhalation.

                                                                  Herbal preparations in liquid dosage forms for oral
                                                                  use.

                                                                  Herbal substance or comminuted herbal substance
                                                                  for infusion preparation for oromucosal or
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for
                                                                  preparation of dilutions for oromucosal or
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for
                                                                  preparation of dilutions for steam inhalation.

                                                                  Herbal preparations in semi-solid dosage forms for
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for use
                                                                  as bath additives.
                                                                  The pharmaceutical form should be described by
                                                                  the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                             Traditional use

                                                                  Indication 1)
                                                                  Traditional herbal medicinal product used for the
                                                                  symptomatic treatment of minor gastro-intestinal
                                                                  complaints such as bloating and minor spasms.




European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 3/13
 Well-established use                                             Traditional use

                                                                  Indication 2)
                                                                  Traditional herbal medicinal product used for the
                                                                  relief of symptoms of common cold.

                                                                  Indication 3)
                                                                  Traditional herbal medicinal product for the
                                                                  treatment of minor ulcers and inflammations of the
                                                                  mouth and throat.

                                                                  Indication 4)
                                                                  Traditional herbal medicinal product used for
                                                                  adjuvant therapy of irritations of skin and mucosae
                                                                  in the anal and genital region, after serious
                                                                  conditions have been excluded by a medical
                                                                  doctor.

                                                                  Indication 5)
                                                                  Traditional herbal medicinal product used for the
                                                                  treatment of minor inflammation of the skin
                                                                  (sunburn), superficial wounds and small boils
                                                                  (furuncles).
                                                                  The product is a traditional herbal medicinal
                                                                  product for use in specified indications exclusively
                                                                  based upon long-standing use.


4.2. Posology and method of administration 4

 Well-established use                                             Traditional use

                                                                  Posology
                                                                  Preparation a)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1.5-4 g of the herbal substance or
                                                                  comminuted herbal substance in 150 ml of boiling
                                                                  water as a herbal infusion
                                                                  Daily dose: 3-4 times
                                                                  Children (6 months - 2 years)
                                                                  Single dose: 0.5-1.0 g
                                                                  Daily dose: 2-4 times

                                                                  Children (2-6 years)
                                                                  Single dose: 1.0-1.5 g
                                                                  Daily dose: 2-4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 1.5-3.0 g
                                                                  Daily dose: 2-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3-10 g of herbal substance
                                                                  or comminuted herbal substance in 100 ml hot
                                                                  water for inhalation

4
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                             Page 4/13
 Well-established use                                             Traditional use

                                                                  Daily dose: several times
                                                                  Children (6-12 years)
                                                                  Single dose: 2-5 g of herbal substance
                                                                  or comminuted herbal substance in 100 ml hot
                                                                  water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: Herbal substance or comminuted
                                                                  herbal substance for infusion preparation for
                                                                  oromucosal use: 1-5 g in 100 ml water, for rinsing
                                                                  and gargling
                                                                  Daily dose: several times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 4.5-5 g herbal substance or
                                                                  comminuted herbal substance per 1 l water for
                                                                  infusion preparation for irrigation
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3-10 g herbal substance or
                                                                  comminuted herbal substance in 100 ml water for
                                                                  infusion preparation for washings and impregnated
                                                                  dressings
                                                                  Daily dose: several times
                                                                  Preparation b)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2 g in 150 ml warm water
                                                                  Daily dose: 3-4 times
                                                                  Preparation c)
                                                                  Indication 3) (for gargling or rinsing)

                                                                  Indication 5) (for washing or impregnated
                                                                  dressings)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10 ml in 150 ml warm water
                                                                  Daily dose: 3-4 times
                                                                  Preparation d)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3 ml in 150 ml water
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml hot water for
                                                                  inhalation
                                                                  Daily dose: 1-2 times




European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                           Page 5/13
 Well-established use                                             Traditional use

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml waterfor gargling or
                                                                  rinsing
                                                                  Daily dose: several times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml water for irrigations
                                                                  Single dose: 5 ml per 1 l water for partial baths
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1.5 ml in 150 ml water for
                                                                  compresses and irrigation
                                                                  Daily dose: several times
                                                                  Preparation e)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 2.5 ml in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml hot water for
                                                                  inhalation
                                                                  Daily dose: several times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2.5 ml in 125 ml water for gargling or
                                                                  rinsing
                                                                  Daily dose: 3-4 times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for compresses
                                                                  and irrigation
                                                                  Single dose: 10 ml per 1 l water for partial baths
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for compresses
                                                                  and irrigation
                                                                  Single dose: 10 ml per 1 l water for partial baths
                                                                  Daily dose: several times
                                                                  Preparation f) (in diluted liquid dosage forms
                                                                  containing approximately 0.47% dry extract)
                                                                  Indication 5) (sun burn)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: apply few drops in a thin layer on the


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 6/13
 Well-established use                                             Traditional use

                                                                  affected area
                                                                  Daily dose: several times

                                                                  Preparation g)
                                                                  Indication 1) and 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose 1.5 ml in 150 ml water for oral use and
                                                                  mouth rinsing or gargling
                                                                  Daily dose: 3-4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 0.7–1 ml in 150 ml water for oral use
                                                                  and mouth rinsing or gargling
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for
                                                                  compresses and irrigation or partial baths
                                                                  Daily dose: several times

                                                                  Preparation h)
                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-3 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1-2 ml in 150 ml warm water for
                                                                  mouth rinsing or gargling
                                                                  Daily dose: up to 4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 0.5-1 ml in 150 ml warm water mouth
                                                                  rinsing or gargling
                                                                  Daily dose: up to 4 times
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l warm water for
                                                                  compresses and irrigation
                                                                  Single dose: 15-30 ml per 5 l warm water for
                                                                  partial baths
                                                                  Daily dose: one to several times

                                                                  Preparation i)
                                                                  Indication 1) and 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2.5-5 ml in 50-100 ml water
                                                                  Daily dose: 3-4 times




European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 7/13
 Well-established use                                             Traditional use

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5-10 ml in 100 ml water for washings
                                                                  and compresses
                                                                  Daily dose: several times

                                                                  Preparation j)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml warm water
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 40 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 100 ml water for rinsing or
                                                                  gargling
                                                                  Daily dose: 3 times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for hip baths
                                                                  Single dose: 40 ml per 1 l water for washings and
                                                                  impregnated dressings
                                                                  Daily dose: one to several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 40 ml per 1 l water for irrigations and
                                                                  impregnated dressings
                                                                  Daily dose: one to several times

                                                                  Preparation k)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 g in 150 ml water
                                                                  Daily dose: up to 4 times
                                                                  Children (6-12 years)
                                                                  Single dose: 0.7 g in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10-20 ml per 1 l hot water for
                                                                  inhalation
                                                                  Daily dose: one to several times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 0.7-1.0 ml in 75 ml water for rinsing
                                                                  or gargling
                                                                  Daily dose: one to several times




European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                             Page 8/13
 Well-established use                                             Traditional use

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 7.5-15 ml per 1 l water for partial
                                                                  baths and irrigations
                                                                  Daily dose: one to several times daily

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10-20 ml per 1 l water for washing,
                                                                  impregnated dressings and partial baths
                                                                  Daily dose: one to several times daily
                                                                  Preparation l)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 100 ml water
                                                                  Daily dose: up to 4 times

                                                                  Children from (6-12 years)
                                                                  Single dose: 2-3 ml in 100 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml per 100 ml warm water for
                                                                  rinsing or garglingDaily dose: 3 to several times

                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 45 ml per 1 l water for washings,
                                                                  impregnated dressings and irrigations
                                                                  Daily dose: 1-2 times
                                                                  Single dose: 30 ml per 1 l water for partial bath or
                                                                  hip bath
                                                                  Daily dose: 1-2 times

                                                                  Preparation m) in semi-solid dosage forms
                                                                  (corresponding to app. 8% herbal substance)
                                                                  Indication 4) and 5)
                                                                  Children (4 weeks - 12 years), adolescents, adults
                                                                  and elderly
                                                                  Single dose: apply a thin layer on the affected
                                                                  area.
                                                                  Daily dose: 2-3 times

                                                                  Preparation n) in semi-solid dosage forms
                                                                  (corresponding to app. 5.5% herbal substance).
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: apply a thin layer on the affected
                                                                  area.



European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 9/13
 Well-established use                                             Traditional use

                                                                  Daily dose: several times

                                                                  Preparation o)
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l for compresses and
                                                                  irrigation
                                                                  Daily dose: one to several times
                                                                  Single dose: 20-40 ml in 20-40 l water for partial
                                                                  baths
                                                                  Daily dose: one time
                                                                  Single dose: 30 ml in 150 l water for full baths
                                                                  Daily dose: one time

                                                                  Children (4 weeks - 12 years)
                                                                  Single dose: 10-20 ml in 10-20 l water for baths
                                                                  Daily dose: one time

                                                                  For all herbal preparations
                                                                  The use is not recommended in specific age groups
                                                                  as specified in 4.4 ‘special warnings and
                                                                  precautions for use‘.

                                                                  Duration of use
                                                                  If the symptoms persist more than one week
                                                                  during the use of the medicinal product, a doctor
                                                                  or a qualified health care practitioner should be
                                                                  consulted.

                                                                  Method of administration

                                                                  Indication 1) Oral use.

                                                                  Indication 2) Inhalation.

                                                                  Indication 3) Oromucosal use.

                                                                  Indication 4) and 5) Cutaneous use, Use as bath
                                                                  additive

Contraindications

4.3. Contraindications

 Well-established use                                             Traditional use

                                                                  Hypersensitivity to the active substance and to
                                                                  other plants of the Asteraceae (Compositae)
                                                                  family.
                                                                  Use as bath additive:

                                                                  Full baths are contraindicated in cases of open
                                                                  wounds, large skin injuries, acute skin diseases,
                                                                  high fever, severe infections, severe circulatory
                                                                  disturbances and cardiac insufficency.

                                                                  Partial baths or hip baths are contraindicated in
                                                                  cases of open wounds, large skin injuries, acute
                                                                  skin diseases, high fever and severe infections.


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                           Page 10/13

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                             Traditional use

                                                                  All methods of administration
                                                                  The use of the herbal preparations b, c, d, f, i, j,
                                                                  and n in children under 12 years of age has not
                                                                  been established due to lack of adequate data.

                                                                  Indication 1)
                                                                  The oral use of the herbal tea for children below 6
                                                                  months of age has not been established due to
                                                                  general considerations of nutrition and fluid intake.

                                                                  The oral use of herbal preparations e, g, k, l in
                                                                  children under 6 years of age has not been
                                                                  established due to lack of adequate data.

                                                                  The oral use of herbal preparations b, d, i, j in
                                                                  children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  Indication 2)
                                                                  The use of herbal preparations d, e, g, h, j, k, l as
                                                                  steam inhalation in children under 12 years of age
                                                                  has not been established due to lack of adequate
                                                                  data.
                                                                  The use of herbal preparation a as steam
                                                                  inhalation in children under 6 years of age has not
                                                                  been established due to lack of adequate data.
                                                                  Indication 3)
                                                                  The use of herbal preparation h, for mouth washes
                                                                  or gargling in children under 6 years of age has
                                                                  not been established due to lack of adequate data.
                                                                  The use of herbal preparations a, c, d, e, i, j, k, l,
                                                                  for mouth washes or gargling in children under 12
                                                                  years of age has not been established due to lack
                                                                  of adequate data.
                                                                  Indication 4)
                                                                  The use of herbal preparation o, m for partial
                                                                  baths or local cutenous use in children under 4
                                                                  weeks of age has not been established due to lack
                                                                  of adequate data.
                                                                  The use of herbal preparations a, d, e, g, h, j k, l,
                                                                  n for partial baths or local cutaneous use in
                                                                  children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  Indication 5)
                                                                  The use of herbal preparation m, o, for partial
                                                                  baths or local cutaneous use in children under 4
                                                                  weeks of age has not been established due to lack
                                                                  of adequate data.
                                                                  The use of herbal preparations a, c, d, e, f, g, i, j,
                                                                  k, l, n (partially) for partial baths or local cutenous
                                                                  use in children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  If the symptoms worsen during the use of the


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                              Page 11/13
 Well-established use                                             Traditional use

                                                                  medicinal product, a doctor or a qualified health
                                                                  care practitioner should be consulted.

                                                                  For tinctures and preparations containing ethanol,
                                                                  the appropriate labelling for ethanol, taken from
                                                                  the ‘Guideline on excipients in the label and
                                                                  package leaflet of medicinal products for human
                                                                  use’, must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                             Traditional use

                                                                  Oral use: For patients after renal transplantation
                                                                  taking high dosages for longer periods (about two
                                                                  months) interactions based on effects on CYP450
                                                                  have been reported.
                                                                  Cutaneous, oromucosal use, inhalation, or as
                                                                  bath additive:
                                                                  None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                             Traditional use

                                                                  Hypersensitivity reactions including severe allergic
                                                                  reaction (dyspnoea, Quincke’s disease, vascular


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 12/13
 Well-established use                                             Traditional use

                                                                  collapse, anaphylactic shock) following mucosal
                                                                  contact with liquid chamomile preparations have
                                                                  been reported. The frequency is not known .
                                                                  If other adverse reactions not mentioned above
                                                                  occur, a doctor or a qualified health care
                                                                  practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1,2
Well-established use                                               Traditional use

                                                                   With regard to the registration application of
                                                                   Article 16d(1) of Directive 2001/83/EC as
                                                                   amended

                                                                   Melaleuca alternifolia (Maiden and Betch) Cheel,
                                                                   M. linariifolia Smith, M. dissitiflora F. Mueller
                                                                   and/or other species of Melaleuca, aetheroleum
                                                                   (tea tree oil)

                                                                   i) Herbal substance

                                                                   Not applicable.

                                                                   ii) Herbal preparations

                                                                   Essential oil



3. Pharmaceutical form
Well-established use                                               Traditional use

                                                                   Herbal preparation in liquid and semi-solid dosage
                                                                   forms for cutaneous use (indication 1-3) or in
                                                                   liquid dosage form for oromucosal use (indication
                                                                   4).

                                                                   The pharmaceutical form should be described by
                                                                   the European Pharmacopoeia full standard term.




1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. monograph (ref.: 01/2008: 1837).


European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith,
M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320930/2012                                                                                                Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                               Traditional use

                                                                   Indication 1)

                                                                   Traditional herbal medicinal product for treatment
                                                                   of small superficial wounds and insect bites.

                                                                   Indication 2)

                                                                   Traditional herbal medicinal product for treatment
                                                                   of small boils (furuncles and mild acne).

                                                                   Indication 3)

                                                                   Traditional herbal medicinal product for the relief
                                                                   of itching and irritation in cases of mild athlete´s
                                                                   foot.

                                                                   Indication 4)

                                                                   Traditional herbal medicinal product for
                                                                   symptomatic treatment of minor inflammation of
                                                                   the oral mucosa.

                                                                   The product is a traditional herbal medicinal
                                                                   product for use in specified indications exclusively
                                                                   based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                               Traditional use

                                                                   Indication 1)

                                                                   Adolescents, adults and elderly
                                                                   Single dose
                                                                   0.03-0.07 ml of undiluted essential oil to be
                                                                   applied to the affected area using a cotton bud
                                                                   1-3 times daily

                                                                   Liquid preparations containing 0.5% to 10% of
                                                                   essential oil to be applied to the affected area
                                                                   1-3 times daily.

                                                                   Indication 2)

                                                                   Adolescents, adults and elderly
                                                                   Single dose
                                                                   Oily liquid or semi-solid preparations containing
                                                                   10% of essential oil, to be applied to the affected
                                                                   area 1-3 times daily or


European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith,
M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320930/2012                                                                                            Page 4/8
Well-established use                                               Traditional use

                                                                   0.7-1 ml of essential oil stirred in 100 ml of
                                                                   lukewarm water to be applied as an impregnated
                                                                   dressing to the affected areas of the skin

                                                                   Undiluted essential oil to be applied to the boil
                                                                   using a cotton bud 2-3 times daily.

                                                                   Indication 3)

                                                                   Adolescents, adults and elderly
                                                                   Single dose
                                                                   Oily liquid or semi-solid preparations containing
                                                                   10% of essential oil, to be applied on the affected
                                                                   area 1-3 times daily.

                                                                   0.17-0.33 ml of essential oil in an appropriate
                                                                   volume of warm water to cover the feet. Soak feet
                                                                   for 5-10 minutes a day.

                                                                   Undiluted essential oil to be applied to the
                                                                   affected area using a cotton bud 2-3 times daily.

                                                                   Indication 4)

                                                                   Adolescents, adults and elderly
                                                                   Single dose
                                                                   0.17–0.33 ml of essential oil to be mixed in
                                                                   100 ml of water for rinse or gargle several times
                                                                   daily.

                                                                   The use in children under 12 years of age is not
                                                                   recommended (see section 4.4 ‘Special warnings
                                                                   and precautions for use’).

                                                                   Duration of use

                                                                   Indication 1)

                                                                   If the symptoms persist longer than 1 week
                                                                   during the use of the medicinal product, a doctor
                                                                   or a qualified health care practitioner should be
                                                                   consulted.

                                                                   Indication 2) and 3)

                                                                   Not to be used for more than 1 month.

                                                                   If the symptoms persist during the use of the
                                                                   medicinal product, a doctor or a qualified health
                                                                   care practitioner should be consulted.

                                                                   Indication 4)

                                                                   If the symptoms persist longer than 5 days during
                                                                   the use of the medicinal product, a doctor or a


European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith,
M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320930/2012                                                                                                Page 5/8
Well-established use                                               Traditional use

                                                                   qualified health care practitioner should be
                                                                   consulted.

                                                                   Method of administration

                                                                   Indication 1), 2) and 3)

                                                                   Cutaneous use.

                                                                   Indication 4)

                                                                   Oromucosal use.

Contraindications

4.3. Contraindications

Well-established use                                              Traditional use

                                                                  Hypersensitivity to the active substance or to
                                                                  colophony.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                               Traditional use

                                                                   The use in children under 12 years of age has not
                                                                   been established due to lack of adequate data.

                                                                   If a rash develops discontinue use.

                                                                   Not to be used orally or as inhalation.

                                                                   Not to be used in eyes or in ears.

                                                                   If symptoms worsen during the use of the
                                                                   medicinal product, a doctor or a qualified health
                                                                   care practitioner should be consulted.

                                                                   Indication 1)

                                                                   If fever or signs of exacerbating skin infection are
                                                                   observed, a doctor or a qualified health care
                                                                   practitioner should be consulted.

                                                                   Indication 2)

                                                                   In cases of severe acne a doctor or a qualified
                                                                   healthcare practitioner shall be consulted.

                                                                   Indication 3)

                                                                   For the eradication of fungal infection a doctor or
                                                                   a qualified healthcare practitioner shall be
                                                                   consulted.




European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith,
M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320930/2012                                                                                              Page 6/8
Well-established use                                               Traditional use

                                                                   Indication 4)

                                                                   Not to be swallowed.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                               Traditional use

                                                                   None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                               Traditional use

                                                                   Adverse skin reactions including smarting pain,
                                                                   mild pruritus, burning sensation, irritation, itching,
                                                                   stinging, erythema, oedema (contact dermatitis)
                                                                   or other allergic reactions have been reported.
                                                                   The frequency is not known.

                                                                   Burn-like skin reactions have been reported. The
                                                                   frequency is rare (<1/1000).

                                                                   If other adverse reactions not mentioned above
                                                                   occur, a doctor or a qualified health care
                                                                   practitioner should be consulted.




European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith,
M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320930/2012                                                                                             Page 7/8

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
    Well-established use                                          Traditional use

                                                                  With regard to the registration application of
                                                                  Article 16d(1) of Directive 2001/83/EC

                                                                  Melilotus officinalis (L.) Lam., herba (melilot)

                                                                  i) Herbal substance

                                                                  Not applicable

                                                                  ii) Herbal preparations

                                                                  a) Comminuted herbal substance

                                                                  b) Powdered herbal substance

                                                                  c)   Liquid extract, ratio of herbal substance to
                                                                       extraction solvent 3 1:3, extraction solvents:
                                                                       ethanol 70% (V/V), rapeseed oil 4



3. Pharmaceutical form
    Well-established use                                          Traditional use

                                                                  a) Comminuted herbal substance as herbal tea,
                                                                  infusion, for oral use

                                                                  b) Herbal substance in solid dosage forms for
                                                                  oral use

                                                                  c) Herbal preparations in semi-solid dosage
                                                                  forms for cutaneous use

                                                                  The pharmaceutical form should be described by
                                                                  the European Pharmacopoeia full standard term.




1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. monograph (ref.: 2120).
3
 Ratio of herbal substance to extraction solvent is defined in general monograph Herbal drug extracts of European
Pharmacopoeia 9.0 as Drug solvent ratio (DSR).

4
    Preparation method described in Farmakopea Polska IV, 1970, p. 198.

European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
EMA/HMPC/44166/2016                                                                                                 Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                          Traditional use

                                                                  Indication 1)

                                                                  Traditional herbal medicinal product to relieve
                                                                  symptoms of discomfort and heaviness of legs
                                                                  related to minor venous circulatory
                                                                  disturbances.

                                                                  The product is a traditional herbal medicinal
                                                                  product for use in specified indications
                                                                  exclusively based upon long-standing use.

                                                                  Indication 2)

                                                                  Traditional herbal medicinal product used for the
                                                                  treatment of minor inflammations of the skin.

                                                                  The product is a traditional herbal medicinal
                                                                  product for use in specified indications
                                                                  exclusively based upon long-standing use.


4.2. Posology and method of administration 5

    Well-established use                                          Traditional use

                                                                  Posology

                                                                  Indication 1)

                                                                  Adults and elderly

                                                                  a) Single dose:

                                                                  Herbal tea: 1.0–1.2 g of comminuted herbal
                                                                  substance in boiling water as an herbal infusion
                                                                  2 times daily

                                                                  Daily dose: 2.0–2.4 g

                                                                  b) Single dose:

                                                                  Powdered herbal substance: 250 mg 3 times
                                                                  daily

                                                                  Daily dose: 750 mg

                                                                  Indication 2)

                                                                  c) Single dose: 3 g of liquid extract, as a
                                                                  cutaneous patch applied to the affected skin


5
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
EMA/HMPC/44166/2016                                                                                              Page 4/7
 Well-established use                                             Traditional use

                                                                  area. Daily dose: 3–6 g (up to two patches).

                                                                  The use in children and adolescents under 18
                                                                  years of age is not recommended (see section
                                                                  4.4 ‘Special warnings and precautions for use’).

                                                                  Duration of use

                                                                  Indication 1)

                                                                  If the symptoms persist longer than 2 weeks
                                                                  during the use of the medicinal product, a
                                                                  doctor or a qualified health care practitioner
                                                                  should be consulted.

                                                                  Indication 2)

                                                                  If the symptoms persist longer than 1 week
                                                                  during the use of the medicinal product, a
                                                                  doctor or a qualified health care practitioner
                                                                  should be consulted.

                                                                  Method of administration

                                                                  Indication 1)

                                                                  Oral use

                                                                  Indication 2)

                                                                  Cutaneous use

Contraindications

4.3. Contraindications

 Well-established use                                             Traditional use

                                                                  Hypersensitivity to the active substance(s).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                             Traditional use

                                                                  The use in children and adolescents under 18
                                                                  years of age has not been established due to
                                                                  lack of adequate data.

                                                                  Indication 1)

                                                                  If the symptoms of thrombophlebitis or
                                                                  subcutaneous induration, sudden swelling of one
                                                                  or both legs, cardiac or renal insufficiency
                                                                  appear during the use of the medicinal product,
                                                                  a doctor or a qualified health care practitioner
                                                                  should be consulted.



European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
EMA/HMPC/44166/2016                                                                                              Page 5/7
 Well-established use                                             Traditional use

                                                                  Indication 2)

                                                                  If symptoms of skin inflammation worsen or
                                                                  signs of skin infections occur during the use of
                                                                  the medicinal product, a doctor or a qualified
                                                                  health care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                             Traditional use

                                                                  None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                             Traditional use

                                                                  Oral use

                                                                  Gastrointestinal complaints have been reported.
                                                                  The frequency is not known.

                                                                  Cutaneous use

                                                                  Allergic reactions have been reported. The
                                                                  frequency is not known.

                                                                  If other adverse reactions not mentioned above
                                                                  occur, a doctor or a qualified health care
                                                                  practitioner should be consulted.




European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
EMA/HMPC/44166/2016                                                                                            Page 6/7

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
Well-established use                                           Traditional use

                                                               With regard to the registration application of
                                                               Article 16d(1) of Directive 2001/83/EC as
                                                               amended

                                                               Melissa officinalis L., folium (Melissa leaf)

                                                               i) Herbal substance

                                                               Not applicable.

                                                               ii) Herbal preparations

                                                               a) Comminuted herbal substance

                                                               b) Powdered herbal substance

                                                               c)   Liquid extract (DER 1:1), extraction
                                                                    solvent ethanol 45-53% V/V

                                                               d) Tincture (ratio of herbal substance to
                                                                    extraction solvent 1:5), extraction solvent
                                                                    ethanol 45-53% V/V

                                                               e) Dried water or ethanol (45-53% V/V) extracts
                                                                    corresponding to the tea, liquid extract and
                                                                    tincture above.



3. Pharmaceutical form
Well-established use                                           Traditional use

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.

                                                               Herbal preparations in solid or liquid dosage forms
                                                               for oral use.

                                                               The pharmaceutical form should be described by
                                                               the European Pharmacopoeia full standard term.




1
 The material complies with the Ph. Eur. monograph (ref. 01/2011:1447).
2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

Community herbal monograph on Melissa officinalis L., folium
EMA/HMPC/196745/2012                                                                                                Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

                                                               Indication 1)

                                                               Traditional herbal medicinal product for relief of
                                                               mild symptoms of mental stress and to aid sleep.

                                                               Indication 2)

                                                               Traditional herbal medicinal product for
                                                               symptomatic treatment of mild gastrointestinal
                                                               complaints including bloating and flatulence.

                                                               The product is a traditional herbal medicinal
                                                               product for use in specified indications exclusively
                                                               based upon long-standing use.


4.2. Posology and method of administration 3

Well-established use                                           Traditional use

                                                               Posology

                                                               Indications 1) and 2)

                                                               Adolescents over 12 years of age, adults and
                                                               elderly

                                                               Single dose

                                                               a) Herbal tea: 1.5-4.5 g of the comminuted herbal
                                                               substance in 150 ml of boiling water as a herbal
                                                               infusion, 1-3 times daily.

                                                               b) Powdered herbal substance: 0.19-0.55 g,
                                                               2-3 times daily.

                                                               c) Liquid extract: 2-4 ml, 1-3 times daily.

                                                               d) Tincture: 2-6 ml, 1-3 times daily.

                                                               e) Dried water or ethanol (45-53% V/V) extracts
                                                               in doses corresponding to the posologies for tea,
                                                               liquid extract and tincture above.

                                                               The use in children under 12 years of age is not
                                                               recommended (see section 4.4. ‘Special warnings
                                                               and precautions for use’).

                                                               Duration of use

                                                               If the symptoms persist longer than 2 weeks
3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

Community herbal monograph on Melissa officinalis L., folium
EMA/HMPC/196745/2012                                                                                             Page 4/7
Well-established use                                           Traditional use

                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Oral use.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

                                                               Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

                                                               Indication 1) and 2)

                                                               The use in children under 12 years of age has not
                                                               been established due to lack of adequate data.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a qualified health
                                                               care practitioner should be consulted.

                                                               For tinctures and liquid extracts containing
                                                               ethanol, the appropriate labelling for ethanol,
                                                               taken from the ‘Guideline on excipients in the
                                                               label and package leaflet of medicinal products for
                                                               human use’, must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                           Traditional use

                                                               No data available.

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               None known.

                                                               If adverse reactions occur, a doctor or a qualified
                                                               health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1, 2
Well-established use                                            Traditional use

With regard to the marketing authorisation                      With regard to the registration application of
application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC
2001/83/EC                                                      Mentha x piperita L., aetheroleum (peppermint
                                                                oil)
Mentha x piperita L., aetheroleum (peppermint
oil)                                                            i) Herbal substance

i) Herbal substance                                             Not applicable

Not applicable                                                  ii) Herbal preparation

ii) Herbal preparation                                          Essential oil

Essential oil



3. Pharmaceutical form
Well-established use                                            Traditional use

Herbal preparations in solid gastro-resistant                   Herbal preparations in liquid or solid dosage forms
dosage forms for oral use.                                      for oral and oromucosal use.

Herbal preparations in liquid or semi-solid dosage              Herbal preparations in liquid dosage forms for
forms for cutaneous use.                                        inhalation.

The pharmaceutical form should be described by                  Herbal preparations in liquid or semi-solid dosage
the European Pharmacopoeia full standard term.                  forms for cutaneous or transdermal use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.




1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 0405)




European Union herbal monograph on Mentha x piperita L., aetheroleum
EMA/HMPC/522410/2013                                                                                                Page 3/12
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

Indication 1)                                                  Indication 1)

Herbal medicinal product for the symptomatic                   Traditional herbal medicinal product used for the
relief of minor spasms of the gastrointestinal                 relief of symptoms in coughs and colds.
tract, flatulence and abdominal pain, especially in
                                                               Indication 2)
patients with irritable bowel syndrome.
                                                               Traditional herbal medicinal product used for the
Indication 2)
                                                               symptomatic relief of localised muscle pain.
Herbal medicinal product for the symptomatic
                                                               Indication 3)
relief of mild tension type headache.
                                                               Traditional herbal medicinal product used for the
                                                               symptomatic relief of localised pruritic conditions
                                                               in intact skin.

                                                               The product is a traditional herbal medicinal
                                                               product for use in specified indications exclusively
                                                               based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                           Traditional use

Posology                                                       Posology

Indication 1)                                                  Indication 1)

Adolescents, adults and elderly                                Inhalation

0.2–0.4 ml in solid gastro–resistant dosage forms.             Adolescents, adults and elderly

Daily dose 0.6–1.2 ml divided in two or three                  0.08-0.16 ml of essential oil up to three times
times daily.                                                   daily. Daily dose 0.08-0.48 ml.

Children between 8 to 11 years of age                          The use in children under 2 years of age is
                                                               contraindicated (see section 4.3
0.2 ml solid gastro–resistant dosage forms three
                                                               ‘Contraindications’).
times daily. Daily dose 0.6 ml.
                                                               The use is not recommended in children between
The use is not recommended in children under 8
                                                               2 years to 11 years of age (see 4.4 ‘Special
years of age (see section 4.4 ‘Special warnings
                                                               warnings and precautions for use’).
and precautions for use’).
                                                               Oral or oromucosal use
See section 6 for content of pulegone and
menthofuran                                                    Adolescents, adults and elderly

Indication 2)                                                  0.08-0.12 ml essential oil, 3-4 times per day.
                                                               Daily dose 0.24-0.48 ml.
Adults and elderly
                                                               The use in children under 2 years of age is
In liquid or semi-solid preparations 10% in
                                                               contraindicated (see section 4.3


European Union herbal monograph on Mentha x piperita L., aetheroleum
EMA/HMPC/522410/2013                                                                                         Page 4/12
Well-established use                                           Traditional use

ethanol.                                                       ‘Contraindications’).

The treatment consists of one application, which               The use is not recommended in children between
can be repeated two times at 15 minutes                        2 to 11 years of age (see 4.4 Special warnings
intervals. One treatment daily.                                and precautions for use).

The use in children and adolescents under 18                   Cutaneous use
years of age is not recommended (see section 4.4
                                                               Adolescents, adults and elderly
‘Special warnings and precautions for use’).
                                                               Nasal ointments 1-5%.
Duration of use
                                                               Up to three times daily
Indication 1)
                                                               The use in children under 2 years of age is
The gastro-resistant dosage forms should be
                                                               contraindicated (see section 4.3
taken until symptoms resolve, usually within one
                                                               ‘Contraindications’).
or two weeks. At times when the symptoms are
more persistent, the intake of gastro-resistant                The use is not recommended in children between
dosage forms can be continued for periods of no                2 to 11 years of age (see 4.4 Special warnings
longer than 3 months per course.                               and precautions for use).

Indication 2)                                                  Indication 1, 2 and 3)

If the symptoms persist or worsen during the use               Cutaneous and transdermal use
of the medicinal product, a doctor should be
                                                               Adults and elderly
consulted.
                                                               Semi-solid and oily preparations 5-20%
Method of administration
                                                               Hydroethanolic preparations 5-10%
Indication 1)
                                                               Up to three times daily
Oral use
                                                               Adolescents
The gastro-resistant dosage forms must be taken
30 minutes before meals and taken whole (see                   Semi-solid preparations 5-15%
section 4.4 ‘Special warnings and precautions for
                                                               Hydroethanolic preparations 3-6%
use’).
                                                               Up to three times daily
Indication 2)
                                                               Children 4 to 11 years of age
Cutaneous use
                                                               Semi-solid preparations 2-10%
The preparation should be rubbed on the skin of
the forehead and temples.                                      Hydroethanolic preparations 2-4%

                                                               Up to three times daily

                                                               See section 6 for content of pulegone and
                                                               menthofuran

                                                               The use in children under 2 years of age is
                                                               contraindicated (see 4.3 ‘Contraindications’).

                                                               The use is not recommended in children below 4
                                                               years of age (see 4.4 Special warnings and
                                                               precautions for use).



European Union herbal monograph on Mentha x piperita L., aetheroleum
EMA/HMPC/522410/2013                                                                                         Page 5/12
Well-established use                                           Traditional use

                                                               Duration of use

                                                               Indication 2 and 3)

                                                               It is not recommended to use the medicinal
                                                               product continuously for more than 2 weeks.

                                                               Indication 1, 2 and 3)

                                                               If the symptoms persist longer than 2 weeks
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Indication 1)

                                                               Inhalation

                                                               The essential oil is added to hot water and the
                                                               vapour is inhaled.

                                                               Oral or oromucosal use

                                                               In lozenges or oral spray.

                                                               Cutaneous and transdermal use

                                                               Apply a thin layer on the chest or on the back or
                                                               around the nostrils.

                                                               Indication 2 and 3)

                                                               Cutaneous and transdermal use

                                                               Apply a thin layer on the affected area.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

Indication 1)                                                  Indication 1, 2 and 3)

Hypersensitivity to peppermint oil or menthol.                 Children under 2 years of age, because menthol
                                                               can induce reflex apnoea and laryngospasm.
Patients with liver disease, cholangitis,
achlorhydria, gallstones and any other biliary                 Children with history of seizures (febrile or not).
disorders.
                                                               Hypersensitivity to peppermint oil or menthol.
Indication 2)

Hypersensitivity to peppermint oil or menthol.




European Union herbal monograph on Mentha x piperita L., aetheroleum
EMA/HMPC/522410/2013                                                                                        Page 6/12

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

Indication 1)                                                  Indication 1)

The use in children under 8 years of age is not                Oral and oromucosal use
recommended due to a lack of data on safety and
                                                               Patients who already suffer from heartburn or
efficacy.
                                                               hiatal hernia, have sometimes an exacerbation of
The gastro-resistant solid dosage forms should be              this symptom after taking peppermint oil.
swallowed whole, i.e. not broken or chewed,                    Treatment should be discontinued in these
because this would release the peppermint oil                  patients.
prematurely, possibly causing local irritation of
                                                               Peppermint oil should be used with caution in
the mouth and oesophagus.
                                                               inflamed and ulcerated conditions of the
Patients, who already suffer from heartburn or                 gastrointestinal tract.
hiatal hernia have sometimes an exacerbation of
                                                               Patients with gallstones and any other biliary
this symptom after taking peppermint oil.
                                                               disorder should be cautious using peppermint oil.
Treatment should be discontinued in these
patients.                                                      Inhalation, cutaneous (nasal application), oral and
                                                               oromucosal use
Indication 2)
                                                               The use in children between 2 and 11 years of age
The use is not recommended in children and
                                                               has not been established due to lack of adequate
adolescents under 18 years of age due to lack of
                                                               data.
data on safety and efficacy.
                                                               Indication 1, 2 and 3)
Eye contact with unwashed hands after the
application of peppermint oil may potentially                  Other medicinal products containing peppermint
cause irritation.                                              oil shall be avoided during the use of this
                                                               medicinal product.
Indication 1 and 2)
                                                               If the symptoms worsen during the use of the
Other medicinal products containing peppermint
                                                               medicinal product, a doctor or a qualified health
oil shall be avoided during the use of this
                                                               care practitioner should be consulted.
medicinal product.
                                                               Cutaneous and transdermal use
If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist                    The use in children between 2 to 3 years of age
should be consulted.                                           has not been established due to lack of adequate
                                                               data.

                                                               Eye contact with unwashed hands after the
                                                               application of peppermint oil may potentially
                                                               cause irritation.

                                                               Peppermint oil should not be applied on broken or
                                                               irritated skin.




European Union herbal monograph on Mentha x piperita L., aetheroleum
EMA/HMPC/522410/2013                                                                                         Page 7/12

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                           Traditional use

Indication 1)                                                  None reported

Use of food or antacids administered at the same
time could cause early release of the capsule
content. Other medicinal products used to
decrease stomach acid, such as histamine-2
blockers and proton pump inhibitors may cause
premature dissolution of the enteric coating and
should be avoided.

Indication 2)

None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

Indication 1)                                                  Indication 1)

Urine and stools with an odour of menthol were                 Inhalation
observed; dysuria and inflammation of the glans
                                                               Apnoea, broncho- and laryngo-constriction in
of the penis have been reported. The frequency is
                                                               hypersensitive patients have been reported. The
not known.
                                                               frequency is not known.
Allergic reactions to menthol were reported, with
                                                               Oral and oromucosal use
headache, bradycardia, muscle tremor, ataxia,
anaphylactic shock and erythematous skin rash.                 Allergic reactions to menthol were reported, with
The frequency is not known.                                    headache, bradycardia, muscle tremor, ataxia,
                                                               anaphylactic shock, contact sensitivity on the
Heartburn, perianal burning blurred vision, dry
                                                               mucosa and erythematous skin rash. The
mouth, nausea and vomiting were frequent in
                                                               frequency is not known.
clinical trials.
                                                               Indication 1, 2 and 3)
Indication 2)
                                                               Cutaneous and transdermal use
Hypersensitivity reactions such as skin rash,
contact dermatitis, and eye irritation have been               Hypersensitivity reactions such as skin rash,
reported. These reactions are usually mild and                 contact dermatitis, and eye irritation have been
transient. The frequency is not known.                         reported. These reactions are the most of the time
                                                               mild and transient. The frequency is not known.
Indication 1 and 2)
                                                               Irritation of the skin and mucosa of the nose is
If other adverse reactions not mentioned above
                                                               possible, after local application.
occur, a doctor or a pharmacist should be
consulted.                                                     Indication 1, 2 and 3)

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a pharmacist should be
                                                               consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1
Well-established use                                              Traditional use

                                                                  With regard to the registration application of
                                                                  Article 16d(1) of Directive 2001/83/EC

                                                                  i) Herbal substance
                                                                     Mentha x piperita L., folium (dried peppermint
                                                                     leaf)

                                                                  ii) Herbal preparations

                                                                      A. Comminuted herbal substance

                                                                      B. Tincture (1:5; ethanol 45% (V/V))

                                                                      C. Tincture (1:5; ethanol 70% (V/V))



3. Pharmaceutical form
Well-established use                                              Traditional use

                                                                  Herbal substance and comminuted herbal
                                                                  substance as herbal tea for oral use.

                                                                  Herbal preparations in solid or liquid dosage forms
                                                                  for oral use.

                                                                  The pharmaceutical form should be described by
                                                                  the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                              Traditional use

                                                                  Traditional herbal medicinal product for the
                                                                  symptomatic relief of digestive disorders such as
                                                                  dyspepsia and flatulence.

                                                                  The product is a traditional herbal medicinal


1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance

European Union herbal monograph on Mentha x piperita L., folium
EMA/HMPC/572705/2014                                                                                                Page 3/7
Well-established use                                              Traditional use

                                                                  product for use in the specified indication
                                                                  exclusively based upon long-standing use.


4.2. Posology and method of administration2

Well-established use                                              Traditional use

                                                                  Posology

                                                                  Children 4-11 years of age and adolescents

                                                                  Herbal tea: 1.0-2.0 g of the herbal substance or
                                                                  the comminuted herbal substance in 100-150 ml
                                                                  of boiling water as a herbal infusion 3 times daily

                                                                  Adults, elderly

                                                                  Single dose

                                                                  Herbal tea: 1.5-3.0 g of the herbal substance or
                                                                  the comminuted herbal substance in 100-150 ml
                                                                  of boiling water as a herbal infusion 3 times daily

                                                                  Preparations B), C) Tincture: 2.0-3.0 ml, 3 times
                                                                  daily.

                                                                  The use is not recommended in children under 4
                                                                  years of age (see section 4.4 Special warnings
                                                                  and precautions for use).

                                                                  Duration of use

                                                                  If the symptoms persist longer than 2 weeks
                                                                  during the use of the medicinal product, a doctor
                                                                  or a qualified health care practitioner should be
                                                                  consulted (see section 4.4 Special warnings and
                                                                  precautions for use).

                                                                  Method of administration

                                                                  Oral use

Contraindications

4.3. Contraindications

Well-established use                                              Traditional use

                                                                  Hypersensitivity to peppermint leaf preparations
                                                                  or to menthol.




2
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

European Union herbal monograph on Mentha x piperita L., folium
EMA/HMPC/572705/2014                                                                                             Page 4/7

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                              Traditional use

                                                                  Patients with gastroesophageal reflux (heartburn)
                                                                  should avoid peppermint leaf preparations,
                                                                  because heartburn may increase.

                                                                  Patients with gallstones and any other biliary
                                                                  disorders should be cautious using peppermint
                                                                  leaf preparations.

                                                                  The use in children under 4 years of age is not
                                                                  recommended due to a lack of adequate data.

                                                                  If the symptoms worsen during the use of the
                                                                  medicinal product, a doctor or a qualified health
                                                                  care practitioner should be consulted.

                                                                  For tinctures and extracts containing ethanol, the
                                                                  appropriate labelling for ethanol, taken from the
                                                                  ‘Guideline on excipients in the label and package
                                                                  leaflet of medicinal products for human use’, must
                                                                  be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                              Traditional use

                                                                  None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                              Traditional use

                                                                  The gastroesophageal reflux may worsen and
                                                                  heartburn may increase. The frequency is not
                                                                  known.

                                                                  See also section 4.4 Special warnings and
                                                                  precautions of use.

                                                                  If other adverse reactions not mentioned above
                                                                  occur, a doctor or a qualified health care
                                                                  practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2, 3
    Well-established use                                       Traditional use

                                                               With regard to the registration application of
                                                               Article 16d(1) of Directive 2001/83/EC as
                                                               amended.

                                                               Menyanthes trifoliata L., folium (bogbean leaf)

                                                               i) Herbal substance

                                                               Not applicable.

                                                               ii) Herbal preparations

                                                               a) Comminuted herbal substance

                                                               b) Powdered herbal substance

                                                               c) Liquid extract (DER 1:1) extraction solvent
                                                               ethanol 25% (V/V)

                                                               d) Tincture (1:5), extraction solvent 45% ethanol
                                                               (V/V)



3. Pharmaceutical form
    Well-established use                                       Traditional use

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.

                                                               Herbal preparations in liquid or solid dosage forms
                                                               for oral use.

                                                               The pharmaceutical form should be described by
                                                               the European Pharmacopoeia full standard term.



2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant
herbal quality guidance.
3
  The material complies with the Ph. Eur. (9.0) (ref: 1605)




European Union herbal monograph on Menyanthes trifoliata L., folium
EMA/HMPC/637833/2018                                                                                            Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                         Traditional use

                                                                 Indication 1)

                                                                 Traditional herbal medicinal product used in
                                                                 temporary loss of appetite.

                                                                 Indication 2)

                                                                 Traditional herbal medicinal product used for the
                                                                 relief of mild digestive disorders such as bloating
                                                                 and flatulence.

                                                                 Indication 3)

                                                                 Traditional herbal medicinal product used for
                                                                 relief of minor articular and muscular pain.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in specified indications
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration 4

    Well-established use                                         Traditional use

    Posology                                                     Posology

                                                                 Indication 1) and 2)

                                                                 Adults and Elderly

                                                                a) Herbal teas

                                                                      a. Herbal tea: 0.4-1.6 g of the comminuted
                                                                        herbal substance in 150 ml of boiling
                                                                        water as herbal tea infusion used 2-4
                                                                        times daily

                                                                        Daily doses: 0.8-4.8 g

                                                                 Indication 1)

                                                                      b. Herbal tea: 0.5-1.5 g of the comminuted
                                                                        herbal substance in 150 ml of water as
                                                                        decoction used 3 times daily

                                                                        Daily doses: 1.5-4.5 g




4
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

European Union herbal monograph on Menyanthes trifoliata L., folium
EMA/HMPC/637833/2018                                                                                             Page 4/8
 Well-established use                                            Traditional use

                                                                b) Powdered herbal substance in single dose 0.5
                                                                      g, 3-4 times daily

                                                                      Daily dose 1.5-2.0 g

                                                                 The use in children and adolescents under 18
                                                                 years of age is not recommended (see section
                                                                 4.4 ‘Special warnings and precautions for use’).

                                                                 Indication 3)

                                                                 Adults and Elderly

                                                                a) Herbal tea: 1.0-2.0 g of the comminuted
                                                                      herbal substance in 150 ml of boiling water
                                                                      as infusion, used 3 times daily

                                                                b) Powdered herbal substance in single doses
                                                                      1.0-2.0 g, 3 times daily

                                                                c) Liquid extract (DER 1:1) extraction solvent
                                                                      ethanol 25% (V/V)

                                                                      Single dose 1-2 ml, 3 times daily

                                                                d) Tincture (DER 1:5), extraction solvent
                                                                      ethanol 45% (V/V)

                                                                      Single dose 1-3 ml, 3 times daily

                                                                 The use in children and adolescents under 18
                                                                 years of age is not recommended (see section
                                                                 4.4 ‘Special warnings and precautions for use’).

                                                                 Duration of use

                                                                 Indication 1) and 2)

                                                                 If the symptoms persist longer than 2 weeks
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Indication 3)

                                                                 If the symptoms persist longer than 4 weeks
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Method of administration

                                                                 Indications 1), 2), 3)

                                                                 Oral use.




European Union herbal monograph on Menyanthes trifoliata L., folium
EMA/HMPC/637833/2018                                                                                          Page 5/8
 Well-established use                                            Traditional use

                                                                 Indication 1)

                                                                 Herbal tea infusion/decoction used 30 minutes
                                                                 before meal.

                                                                 Indication 2)

                                                                 Herbal tea infusion used between meals.

Contraindications

4.3. Contraindications

 Well-established use                                            Traditional use

                                                                 Hypersensitivity to the active substance.

                                                                 Active gastric or duodenal ulcer.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 Indication 1) and 2)

                                                                 The use in children and adolescents under 18
                                                                 years of age has not been established due to
                                                                 lack of adequate data.

                                                                 If the symptoms worsen during the use of the
                                                                 medicinal product, a doctor or a qualified health
                                                                 care practitioner should be consulted.

                                                                 Indication 3)

                                                                 The use in children and adolescents under 18
                                                                 years of age has not been established due to
                                                                 lack of adequate data.

                                                                 If the symptoms worsen during the use of the
                                                                 medicinal product, a doctor or a qualified health
                                                                 care practitioner should be consulted.

                                                                 Patients with articular pain accompanied by
                                                                 swelling of joints, redness or fever should be
                                                                 examined by a doctor.

                                                                 For tinctures and extracts containing ethanol,
                                                                 the appropriate labelling for ethanol, taken from
                                                                 the ‘Guideline on excipients in the label and
                                                                 package leaflet of medicinal products for human
                                                                 use’, must be included.




European Union herbal monograph on Menyanthes trifoliata L., folium
EMA/HMPC/637833/2018                                                                                             Page 6/8

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                            Traditional use

                                                                 None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 None known.

                                                                 If adverse reactions occur, a doctor or a
                                                                 qualified health care practitioner should be
                                                                 consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended

                                                                Achillea Millefolium L., flos (yarrow flower)

                                                                i) Herbal substance

                                                                Dried inflorescence.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Liquid extract (DER 1:5.8), extraction solvent
                                                                liquor vine : ethanol 96% V/V (91:9 m/m)



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal substance and comminuted herbal
                                                                substance as herbal tea for oral use.

                                                                Herbal substance for infusion preparation for
                                                                cutaneous use.

                                                                Herbal preparation in liquid dosage forms for oral
                                                                use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)


1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2 The material complies with Ph. Helv.VII: Millefolii flos, (ref.: Ph.Helv.10-2006, 10.0/CH 184).

Community herbal monograph on Achillea millefolium L., flos
EMA/HMPC/143949/2010                                                                                               Page 2/6
Well-established use                                          Traditional use

                                                              Traditional herbal medicinal product used for
                                                              temporary loss of appetite.

                                                              Indication 2)

                                                              Traditional herbal medicinal product for the
                                                              symptomatic treatment of mild, spasmodic gastro-
                                                              intestinal complaints including bloating and
                                                              flatulence.

                                                              Indication 3)

                                                              Traditional herbal medicinal product for the
                                                              treatment of small superficial wounds.

                                                              Indication 4)

                                                              Traditional herbal medicinal product for the
                                                              symptomatic treatment of minor spasm
                                                              associated with menstrual periods.

                                                              The product is a traditional herbal medicinal
                                                              product for use in specified indications exclusively
                                                              based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                          Traditional use

                                                              Posology

                                                              Adolescents, adults and elderly

                                                              Indications 1) and 2)

                                                              Herbal tea: 1.5-2 g of herbal substance or
                                                              comminuted herbal substance in 250 ml boiling
                                                              water as a herbal infusion 2 times daily.

                                                              For the indication “loss of appetite”, the herbal tea
                                                              is to be taken 30 minutes before meals.

                                                              Indication 2)

                                                              Liquid extract: 10-20 drops 2-3 times daily.

                                                              Indication 4)

                                                              Herbal tea: 1-2 g of herbal substance or
                                                              comminuted herbal substance in 250 ml boiling
                                                              water as an herbal infusion 2-3 times daily.

                                                              Indication 3)

                                                              Herbal substance for infusion preparation for
                                                              cutaneous use: 1.5 g of herbal substance in 250


Community herbal monograph on Achillea millefolium L., flos
EMA/HMPC/143949/2010                                                                                       Page 3/6
Well-established use                                          Traditional use

                                                              ml water 2–3 times daily.

                                                              The use in children under 12 years of age is not
                                                              recommended (see section 4.4 ‘Special warnings
                                                              and precautions for use’).

                                                              Duration of use

                                                              Indications 1) and 2)

                                                              If the symptoms persist longer than 2 weeks
                                                              during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
                                                              consulted.

                                                              Indications 3) and 4)

                                                              If the symptoms persist longer than 1 week
                                                              during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
                                                              consulted.

                                                              Method of administration

                                                              Indications 1), 2) and 4)

                                                              Oral use.

                                                              Indication 3)

                                                              Cutaneous use: to be applied on the affected area
                                                              in a form of an impregnated dressing.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

                                                              Hypersensitivity to the active substance and to
                                                              other plants of the Asteraceae (Compositae)
                                                              family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

                                                              Indications 1-4)

                                                              The use in children under 12 years of age has not
                                                              been established due to lack of adequate data.

                                                              If the symptoms worsen during the use of the
                                                              medicinal product, a doctor or a qualified health
                                                              care practitioner should be consulted.

                                                              Indication 3)


Community herbal monograph on Achillea millefolium L., flos
EMA/HMPC/143949/2010                                                                                     Page 4/6
Well-established use                                          Traditional use

                                                              If signs of skin infection are observed, medical
                                                              advice should be sought.

                                                              For tinctures, extracts containing ethanol, the
                                                              appropriate labelling for ethanol, taken from the
                                                              ‘Guideline on excipients in the label and package
                                                              leaflet of medicinal products for human use’, must
                                                              be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                          Traditional use

                                                              None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

                                                              Hypersensitivity reactions of the skin have been
                                                              reported. The frequency is not known.

                                                              If other adverse reactions not mentioned above
                                                              occur, a doctor or a qualified health care
                                                              practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended


                                                                Commiphora molmol Engler, gummi-resina
                                                                (myrrh)


                                                                i) Herbal substance
                                                                   Not applicable


                                                                ii) Herbal preparations
                                                                   Tincture (ratio of herbal substance to extraction
                                                                   solvent 1:5), extraction solvent ethanol 90 %
                                                                   V/V)



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparation in liquid dosage forms for
                                                                oromucosal or cutaneous use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product for treatment
                                                                of minor ulcers and inflammation in the mouth


1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1349 corrected 6.0).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

Community herbal monograph on Commiphora molmol Engler, gummi-resina

EMA/HMPC/96911/2010                                                                                                  Page 2/6
                                                            (stomatitis and gingivitis).

                                                            Indication 2)

                                                            Traditional herbal medicinal product for treatment
                                                            of minor wounds and small boils (furuncles).

                                                            The product is a traditional herbal medicinal
                                                            product for use in specified indications exclusively
                                                            based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                        Traditional use

                                                            Posology

                                                            Oromucosal use

                                                            Indication 1)

                                                            Adolescents, adults and elderly

                                                            i) 0.5-5 ml of tincture in 150 ml of water for
                                                                 rinsing or gargling 3 times daily.

                                                            or

                                                            ii) The undiluted tincture is applied to the affected
                                                                 areas with a cotton bud 2-3 times daily.

                                                            The use in children under 12 years of age is not
                                                            recommended (see section 4.4 ‘Special warnings
                                                            and precautions for use’).

                                                            Cutaneous use

                                                            Indication 2)

                                                            Adolescents, adults and elderly

                                                            The wound or furuncle is dabbed 2-3 times daily
                                                            with undiluted (preferably) or diluted tincture in
                                                            water.

                                                            The use in children under 12 years of age is not
                                                            recommended (see section 4.4 ‘Special warnings
                                                            and precautions for use’).

                                                            Duration of use

                                                            If the symptoms persist after 1 week during the use
                                                            of the medicinal product, a doctor or a qualified
                                                            health care practitioner should be consulted.

                                                            Method of administration

                                                            Oromucosal and cutaneous use.


Community herbal monograph on Commiphora molmol Engler, gummi-resina

EMA/HMPC/96911/2010                                                                                         Page 3/6

Contraindications

4.3. Contraindications

Well-established use                                       Traditional use

                                                           Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                        Traditional use

                                                            Indications 1) and 2)

                                                            The use in children under 12 years of age is not
                                                            recommended due to lack of adequate data.

                                                            If the symptoms worsen during the use of the
                                                            medicinal product, a doctor or a qualified health
                                                            care practitioner should be consulted.

                                                            The appropriate labelling for ethanol, taken from
                                                            the ‘Guideline on excipients in the label and
                                                            package leaflet of medicinal products for human
                                                            use’, must be included.

                                                            Indication 2)

                                                            If fever or signs of exacerbating skin infection are
                                                            observed, a doctor or a qualified health care
                                                            practitioner should be consulted.

                                                            Small boils (furuncles) in the face should be
                                                            treated by a medical doctor.

                                                            Eye contact with myrrh tincture should be
                                                            avoided.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                        Traditional use

                                                            None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                        Traditional use

                                                            Allergic skin reactions have been reported. The
                                                            frequency is not known.

                                                            The tincture contains alcohol, which may cause a
                                                            transient pain and irritation on application to the
                                                            mucosa or skin.

                                                            If other adverse reactions not mentioned above
                                                            occur, a doctor or a qualified health care
                                                            practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2, 3
    Well-established use                                         Traditional use

                                                                 With regard to the registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC as
                                                                 amended

                                                                 Vaccinium myrtillus L., fructus recens (Bilberry
                                                                 fruit, fresh)

                                                                 i) Herbal substance

                                                                     Not applicable.

                                                                 ii) Herbal preparations

                                                                     Dry extract (DER 153-76:1) extraction solvent
                                                                     methanol 70% V/V containing
                                                                     36% anthocyanosides, corresponding to
                                                                     25% anthocyanidins



3. Pharmaceutical form
    Well-established use                                         Traditional use

                                                                 Herbal preparations in solid dosage forms for oral
                                                                 use.

                                                                 The pharmaceutical form should be described by
                                                                 the European Pharmacopoeia full standard term.




2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
  The material complies with the Ph. Eur. monograph (ref.: 1602)


European Union herbal monograph on Vaccinium myrtillus L., fructus recens
EMA/HMPC/375808/2014                                                                                                 Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

                                                                 Indication 1)
                                                                 Traditional herbal medicinal product to relieve
                                                                 symptoms of discomfort and heaviness of legs
                                                                 related to minor venous circulatory disturbances.

                                                                 Indication 2)

                                                                 Traditional herbal medicinal product to relieve
                                                                 symptoms of cutaneous capillary fragility.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                            Traditional use


                                                                 Posology

                                                                 Adults and elderly
                                                                 Indication 1) and 2)
                                                                 Single dose: 80-180 mg
                                                                 Daily dose: up to 160-540 mg

                                                                 The use in children and adolescents under 18
                                                                 years of age is not recommended (see section
                                                                 4.4 ‘Special warnings and precautions for use’).


                                                                 Duration of use

                                                                 Indication 1) and 2)

                                                                 The recommended duration of use is 4 weeks.

                                                                 If the symptoms persist longer than 2 weeks
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Method of administration

                                                                 Indication 1) and 2)
                                                                 Oral use.




European Union herbal monograph on Vaccinium myrtillus L., fructus recens
EMA/HMPC/375808/2014                                                                                           Page 4/7

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 The use in children and adolescents under
                                                                 18 years of age has not been established due to
                                                                 lack of adequate data.

                                                                 If there is inflammation of the skin,
                                                                 thrombophlebitis or subcutaneous induration,
                                                                 severe pain, ulcers, sudden swelling of one or
                                                                 both legs, cardiac or renal insufficiency, a doctor
                                                                 should be consulted.

                                                                 If the symptoms worsen or persist longer than
                                                                 2 weeks during the use of the medicinal product,
                                                                 a doctor or a qualified health care practitioner
                                                                 should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                            Traditional use

                                                                 None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 None known.

                                                                 If adverse reactions occur, a doctor or a qualified
                                                                 health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2, 3
    Well-established use                                         Traditional use

                                                                 With regard to the registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC as
                                                                 amended

                                                                 Vaccinium myrtillus L., fructus siccus (Bilberry
                                                                 fruit, dried)

                                                                 i) Herbal substance

                                                                 Ripe, dry fruits

                                                                 ii) Herbal preparations

                                                                 Comminuted herbal substance



3. Pharmaceutical form
    Well-established use                                         Traditional use

                                                                 Herbal substance or comminuted herbal
                                                                 substance as herbal tea for oral use or for
                                                                 decoction preparation for oromucosal use.

                                                                 The pharmaceutical form should be described by
                                                                 the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                         Traditional use

                                                                 Indication 1)

                                                                 Traditional herbal medicinal product for
                                                                 symptomatic treatment of mild diarrhoea.




2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
  The material complies with the Ph. Eur. monograph (ref.: 1588)


European Union herbal monograph on Vaccinium myrtillus L., fructus siccus
EMA/HMPC/678995/2013                                                                                                 Page 3/7
    Well-established use                                         Traditional use

                                                                 Indication 2)

                                                                 Traditional herbal medicinal product for
                                                                 symptomatic treatment of minor inflammations
                                                                 of the oral mucosa.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration4

    Well-established use                                         Traditional use

                                                                 Posology
                                                                 Adolescents, adults and elderly
                                                                 Indication 1)

                                                                 Herbal tea: 15-60 g of herbal substance or
                                                                 comminuted herbal substance as a decoction, in
                                                                 divided doses of 5-15 g in 250 ml of water, 3-4
                                                                 times daily.
                                                                 Indication 2)

                                                                 Herbal substance or comminuted herbal
                                                                 substance for decoction preparation for
                                                                 oromucosal use:
                                                                 20 g of herbal substance or comminuted herbal
                                                                 substance in 200 ml of water.

                                                                 Rinse the mouth several times daily.

                                                                 The use in children under 12 years of age is not
                                                                 recommended (see 4.4 ‘Special warnings and
                                                                 precautions for use’).


                                                                 Duration of use

                                                                 Indication 1)

                                                                 If the symptoms persist longer than 3 days
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Indication 2)

                                                                 If the symptoms persist longer than 1 week
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be

4
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Vaccinium myrtillus L., fructus siccus
EMA/HMPC/678995/2013                                                                                            Page 4/7
 Well-established use                                            Traditional use

                                                                 consulted.

                                                                 Method of administration

                                                                 Indication 1)
                                                                 Oral use.
                                                                 Indication 2)
                                                                 Oromucosal use.

Contraindications

4.3. Contraindications

 Well-established use                                            Traditional use

                                                                 Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 The use in children under 12 years of age has
                                                                 not been established due to lack of adequate
                                                                 data.

                                                                 Indication 1)

                                                                 If the symptoms worsen or persist longer than
                                                                 3 days during the use of the medicinal product, a
                                                                 doctor or a qualified health care practitioner
                                                                 should be consulted.

                                                                 Indication 2)

                                                                 If the symptoms worsen or persist longer than
                                                                 1 week during the use of the medicinal product,
                                                                 a doctor or a qualified health care practitioner
                                                                 should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                            Traditional use

                                                                 None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 None known.

                                                                 If adverse reactions occur, a doctor or a qualified
                                                                 health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Oenothera biennis L. or Oenothera lamarckiana
                                                                L., oleum (evening primrose oil)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Fatty oil obtained from seeds of Oenothera
                                                                biennis L. or Oenothera lamarckiana L. by
                                                                extraction and/or expression.



3. Pharmaceutical form
    Well-established use                                        Traditional use

                                                                Herbal preparation in solid dosage forms for oral
                                                                use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Traditional herbal medicinal product for the
                                                                symptomatic relief of itching in acute and
                                                                chronic dry skin conditions exclusively based
                                                                upon long-standing use.


1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. monograph (ref.: 01/2010:2104)


European Union herbal monograph on Oenothera biennis L. or Oenothera lamarckiana L., oleum
EMA/HMPC/753041/2017                                                                                                Page 3/6
4.2. Posology and method of administration

 Well-established use                                          Traditional use

                                                               Posology

                                                               Adolescents, adults and elderly

                                                               Single dose: 2-3 g Daily dose: 4-6 g

                                                               The use in children under 12 years of age is not
                                                               recommended (see section 4.4 ‘Special
                                                               warnings and precautions for use’).

                                                               Duration of use

                                                               If the symptoms persist longer than 8 weeks
                                                               during the use of the medicinal product, a
                                                               doctor or a qualified health care practitioner
                                                               should be consulted.

                                                               Method of administration

                                                               Oral use

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

                                                               Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                          Traditional use

                                                               The use in children under 12 years of age has
                                                               not been established due to lack of adequate
                                                               data.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                          Traditional use

                                                               None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                          Traditional use

                                                               Gastrointestinal effects, indigestion, nausea,
                                                               softening of stool, rise in temperature,
                                                               hypersensitive reactions like exanthema and
                                                               headache have been reported. The frequency is
                                                               not known.

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
 Well-established use                                           Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC

                                                                Olea europaea L., folium (olive leaf)

                                                                i) Herbal substance

                                                                Fresh or dried leaves

                                                                ii) Herbal preparations

                                                                    a) Comminuted dried leaves

                                                                    b) Powdered dried leaves



3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Herbal substance or comminuted herbal
                                                                substance as herbal tea for oral use.

                                                                Powdered dried leaves in solid dosage forms for
                                                                oral use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.


4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                           Traditional use

                                                                Traditional herbal medicinal product used to
                                                                promote the renal elimination of water, in mild
                                                                cases of water retention after serious conditions
                                                                have been excluded by a medical doctor.

                                                                The product is a traditional herbal medicinal

1 The material complies with the Ph. Eur. monograph (ref.: 1878).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

European Union herbal monograph on Olea europaea L., folium
EMA/HMPC/359238/2016                                                                                                 Page 3/7
    Well-established use                                      Traditional use

                                                              product for use in specified indication
                                                              exclusively based upon long-standing use.


4.2. Posology and method of administration 3

    Well-established use                                      Traditional use

                                                              Posology

                                                              Adults and elderly

                                                              i) Herbal substance

                                                              Herbal tea: 10 g of fresh leaves or 5 g of dried
                                                              leaves in 150 ml of water as a decoction 2 times
                                                              daily (morning and evening)

                                                              Decoction time: allow to simmer to reach 100
                                                              ml of decoction.

                                                              i) Herbal substance and ii) herbal preparation

                                                              Dried leaves or a) comminuted dried leaves for
                                                              infusion:

                                                              Single dose: 6–10 g up to 3 times daily.

                                                              Daily dose: 6–30 g

                                                              ii) Herbal preparation

                                                              b) Powdered dried leaves:

                                                              Single dose: 275 mg 3-5 times daily or

                                                              210–400 mg 3 times daily.

                                                              Daily dose: 630–1375 mg.

                                                              The use in children and adolescents under 18
                                                              years of age is not recommended (see section
                                                              4.4 ‘Special warnings and precautions for use’).

                                                              Duration of use

                                                              The herbal substance is traditionally used over a
                                                              period of 2-4 weeks.

                                                              If the symptoms persist longer than one week
                                                              during the use of the medicinal product, a
                                                              doctor or a qualified health care practitioner
                                                              should be consulted.

                                                              Method of administration

                                                              Oral use


3
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev. 1).

European Union herbal monograph on Olea europaea L., folium
EMA/HMPC/359238/2016                                                                                            Page 4/7

Contraindications

4.3. Contraindications

 Well-established use                                         Traditional use

                                                              Hypersensitivity to the active substance.

                                                              Herbal substance and herbal preparation a)

                                                              Conditions where a reduced fluid intake is
                                                              recommended (e.g. severe cardiac or renal
                                                              disease).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                         Traditional use

                                                              Patients with cardiac disease or renal
                                                              impairment should seek medical advice before
                                                              taking Olea medication.

                                                              The use in children and adolescents under
                                                              18 years of age has not been established due to
                                                              lack of adequate data.

                                                              If symptoms worsen during the use of the
                                                              medicinal product, a medical doctor or a
                                                              qualified health care practitioner should be
                                                              consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                         Traditional use

                                                              None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                         Traditional use

                                                              None known.

                                                              If adverse reactions occur, a doctor or a
                                                              qualified health care practitioner should be
                                                              consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1,2
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended

                                                                Ononis spinosa L., radix (Restharrow root)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Comminuted herbal substance.



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Traditional herbal medicinal product used to
                                                                increase the amount of urine to achieve flushing
                                                                of the urinary tract as an adjuvant in minor
                                                                urinary complaints.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication
                                                                exclusively based upon long-standing use.



1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the Ph. Eur. monograph (ref.: 01/2008:1879).

Community herbal monograph on Ononis spinosa L., radix
EMA/HMPC/138317/2013                                                                                                 Page 2/5
4.2. Posology and method of administration 3

Well-established use                                          Traditional use

                                                              Posology

                                                              Adolescents, adults and elderly

                                                              Herbal tea: 2 – 3 g of comminuted herbal
                                                              substance in 150 ml of boiling water as a herbal
                                                              infusion up to 3 - 4 times daily corresponding to
                                                              the maximum daily dose of 12 g.

                                                              The use in children under 12 years of age is not
                                                              recommended (see section 4.4 ‘Special warnings
                                                              and precautions for use’).

                                                              Duration of use

                                                              If the symptoms persist longer than 1 week
                                                              during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
                                                              consulted.

                                                              Method of administration

                                                              Oral use.

Contraindications

4.3. Contraindications

Well-established use                                         Traditional use

                                                             Hypersensitivity to the active substance.

                                                             Conditions where a reduced fluid intake is
                                                             recommended (e.g. severe cardiac or renal
                                                             disease).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

                                                              The use in children under 12 years of age has not
                                                              been established due to lack of adequate data.

                                                              To ensure an increase of the amount of urine,
                                                              adequate fluid intake is required during the
                                                              treatment.

                                                              If urinary tract complaints worsen and symptoms
                                                              such as fever, dysuria, spasm, or blood in the
                                                              urine occur during the use of medicinal product, a
                                                              doctor or a qualified health care practitioner
                                                              should be consulted.

3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

Community herbal monograph on Ononis spinosa L., radix
EMA/HMPC/138317/2013                                                                                             Page 3/5

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                     Traditional use

                                                         None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                     Traditional use

                                                         None known.

                                                         If adverse reactions occur, a doctor or a qualified
                                                         health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 3, 4
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended

                                                                Origanum dictamnus L., herba (Dittany of Crete
                                                                herb)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Comminuted herbal substance.



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Comminuted herbal substance for infusion or
                                                                decoction preparation for cutaneous use.

                                                                The pharmaceutical form should be described by
                                                                full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product used for the

3
  Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a
monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State.
4
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.


Community herbal monograph on Origanum dictamnus L., herba
EMA/HMPC/200429/2012                                                                                                 Page 3/7
Well-established use                                          Traditional use

                                                              relief of cough associated with cold.

                                                              Indication 2)

                                                              Traditional herbal medicinal product used for the
                                                              relief of mild gastrointestinal disorders.

                                                              Indication 3)

                                                              Traditional herbal medicinal product used for the
                                                              relief of minor skin inflammations and bruises.

                                                              The product is a traditional herbal medicinal
                                                              product for use in specified indications exclusively
                                                              based upon long-standing use.


4.2. Posology and method of administration 5

Well-established use                                          Traditional use

                                                              Posology

                                                              Indications 1) and 2)

                                                              Adults and elderly

                                                              Single dose
                                                              Herbal tea: 1.5 – 7 g of the comminuted herbal
                                                              substance in 150 ml of boiling water (allow steep
                                                              for 2 – 4 minutes) as a herbal infusion, 3 times
                                                              daily.
                                                              Daily dose: 4.5 – 21 g

                                                              The use in children and adolescents under 18
                                                              years of age is not recommended (see section 4.4
                                                              ‘Special warnings and precautions for use’).

                                                              Indication 3)

                                                              Adolescents, adults and elderly

                                                              Comminuted herbal substance for infusion or
                                                              decoction preparation for cutaneous use:
                                                              30 – 75 g of comminuted herbal substance in
                                                              1 l of water.

                                                              Apply on the affected area, 2 to 5 times daily, in
                                                              the form of a wet, impregnated dressing.

                                                              The use in children under 12 years of age is not
                                                              recommended (see section 4.4 ‘Special warnings
                                                              and precautions for use’).


5
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


Community herbal monograph on Origanum dictamnus L., herba
EMA/HMPC/200429/2012                                                                                             Page 4/7
Well-established use                                         Traditional use

                                                             Duration of use

                                                             Indication 1)

                                                             If the symptoms persist longer than 1 week
                                                             during the use of the medicinal product, a doctor
                                                             or a qualified health care practitioner should be
                                                             consulted.

                                                             Indications 2) and 3)

                                                             If the symptoms persist longer than 2 weeks
                                                             during the use of the medicinal product, a doctor
                                                             or a qualified health care practitioner should be
                                                             consulted.

                                                             Method of administration

                                                             Oral use.

                                                             Cutaneous use.

Contraindications

4.3. Contraindications

Well-established use                                         Traditional use

                                                             Hypersensitivity to the active substance or to
                                                             other plants of the Lamiaceae (Labiatae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                         Traditional use

                                                             Indications 1) and 2)

                                                             The use in children and adolescents under
                                                             18 years of age has not been established due to
                                                             lack of adequate data.

                                                             Indication 1)

                                                             If the symptoms worsen during the use of the
                                                             medicinal product or if dyspnoea, high fever or
                                                             purulent sputum occurs, a doctor or a qualified
                                                             health care practitioner should be consulted.

                                                             Indication 3)

                                                             The use in children under 12 years of age has not
                                                             been established due to lack of adequate data.




Community herbal monograph on Origanum dictamnus L., herba
EMA/HMPC/200429/2012                                                                                      Page 5/7

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                         Traditional use

                                                             None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                         Traditional use

                                                             None known.

                                                             If adverse reactions occur, a doctor or a qualified
                                                             health care practitioner should be consulted.