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 composition, 2
Well-established use                                              Traditional use

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

                                                                  Herniaria glabra L., H. hirsuta L., H. incana Lam.,
                                                                  herba (rupturewort) or a mixture of them

                                                                  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 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



 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 Monograph in the Austrian Pharmacopoeia (monograph ÖAB 2010/056)



European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana
Lam., herba
EMA/HMPC/554043/2018                                                                                                Page 3/6
Well-established use                                              Traditional use

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


4.2. Posology and method of administration3

Well-established use                                              Traditional use

                                                                  Posology

                                                                  Adults and Elderly
                                                                  Herbal tea: 1.5-3 g of comminuted herbal
                                                                  substance in 150 ml of boiling water as a herbal
                                                                  infusion or in 150 ml water as decoction 3-5 times
                                                                  daily.

                                                                  Maximum daily dose: 10 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’).

                                                                  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.

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


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 Herniaria glabra L., H. hirsuta L., H. incana
Lam., herba
EMA/HMPC/554043/2018                                                                                             Page 4/6
Well-established use                                              Traditional use

                                                                  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.

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 composition1
 Well-established use                                           Traditional use

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


                                                                Aesculus hippocastanum L., cortex (horse-
                                                                chestnut bark)


                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Powdered herbal substance

                                                                Dry extract (DER 7.0-8.5:1), extraction solvent
                                                                water



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.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                           Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product for relief of
                                                                symptoms of discomfort and heaviness of legs


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 Aesculus hippocastanum L., cortex
EMA/HMPC/596130/2022                                                                                                 Page 3/7
 Well-established use                                          Traditional use

                                                               related to minor venous circulatory
                                                               disturbances.

                                                               Indication 2)

                                                               Traditional herbal medicinal product for
                                                               symptomatic relief of itching and burning
                                                               associated with haemorrhoids, after serious
                                                               conditions have been excluded by a medical
                                                               doctor.

                                                               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

                                                               Indication 1) and 2)

                                                               Adults and elderly

                                                               Powdered herbal substance

                                                               Single dose: 550 mg, 2 to 3 times daily

                                                               Daily dose: 1100 mg to 1650 mg

                                                               Dry extract

                                                               Single dose: 200 mg, 2 times daily

                                                               Daily dose: 400 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

                                                               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




European Union herbal monograph on Aesculus hippocastanum L., cortex
EMA/HMPC/596130/2022                                                                                         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.

                                                               Indication 1)

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

                                                               Indication 2)

                                                               If rectal bleeding occurs, a doctor 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 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
                                                               Aesculus hippocastanum L., semen (horse
Aesculus hippocastanum L., semen (horse                        chestnut seed)
chestnut seed)
                                                               i) Herbal substance
i) Herbal substance
                                                               Not applicable
Not applicable
                                                               ii) Herbal preparations
ii) Herbal preparations
                                                               a) Dry extract corresponding to a specified
Dry extracts3 (extraction solvent ethanol 40-80%                    amount of triterpene glycosides, calculated as
V/V) standardised to contain 6.5-10% triterpene                     protoaescigenin4, extraction solvent ethanol
glycosides, calculated as protoaescigenin4.                         25-50% V/V

                                                               b) Liquid extract (DER 1:3.5-5) , extraction
                                                                    solvent ethanol 50% V/V

                                                               c)   Dry extract (DER 5-10:1), extraction solvent
                                                                    methanol 80% V/V

                                                               d) Dry extract (DER 5-8:1), extraction solvent
                                                                    methanol 80% V/V

                                                               e) Dry extract (DER 4.5-5.5:1), extraction
                                                                    solvent ethanol 50% V/V

                                                               f)   Dry extract (DER 5-7:1), extraction solvent
                                                                    ethanol 60% V/V

                                                               g) Liquid extract (DER 1:1.5-2.5), extraction
                                                                    solvent ethanol 55% V/V

                                                               h) Liquid extract (DER 1:2), extraction solvent

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.: 1830)
3
  The composition of the extraction solvent and the content of triterpene glycosides must be specified in the individual
extract. The herbal preparation complies with the Ph. Eur. monograph (ref.: 1829)
4
  In 2017, new lower acceptance criteria for the content of triterpene glycosides using a more specific method, i.e. LC
assay, were introduced in the Ph. Eur. monographs 1830 and 1829 and the previous method, i.e. the absorption assay was
superseded. Previously, the standardised extract in the WEU monograph was declared to contain 16-28% triterpene
glycosides calculated as aescin (photometric method) with reference to the superseded version of the Ph.Eur. monograph
1829.


European Union herbal monograph on Aesculus hippocastanum L., semen
EMA/HMPC/638242/2018                                                                                                Page 3/9
Well-established use                                         Traditional use

                                                                  ethanol 19% m/m

                                                             i)   Dry extract (DER 3-6:1), extraction solvent
                                                                  water



3. Pharmaceutical form
Well-established use                                         Traditional use

Herbal preparations in modified or immediate                 Herbal preparations in semi-solid dosage forms
release dosage forms for oral use.                           for cutaneous use.

The pharmaceutical form should be described by               Herbal preparations in solid or liquid dosage forms
the European Pharmacopoeia full standard term.               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

Herbal medicinal product for treatment of chronic             Indication 1)
venous insufficiency, which is characterised by
                                                              Traditional herbal medicinal product to relieve
swollen legs, varicose veins, a feeling of
                                                              symptoms of discomfort and heaviness of legs
heaviness, pain, tiredness, itching, tension and
                                                              related to minor venous circulatory disturbances.
cramps in the calves.
                                                              Indication 2)

                                                              Traditional herbal medicinal product for relief of
                                                              signs of bruises, such as local oedema and
                                                              haematoma.

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




European Union herbal monograph on Aesculus hippocastanum L., semen
EMA/HMPC/638242/2018                                                                                       Page 4/9
4.2. Posology and method of administration

Well-established use                                          Traditional use

Posology                                                      Posology

Adults and elderly                                            Indication 1)

Standardised dry extract corresponding to a                   Herbal preparations a)-f)
content of 21 mg triterpene glycosides calculated
                                                              Adults and elderly
as protoaescigenin5 2 times daily.
                                                              a) In semi-solid dosage forms: herbal
There is no relevant indication in children under
                                                                   preparation in an amount equivalent to 0.4%
12 years of age.
                                                                   triterpene glycosides, calculated as
The use in adolescents under 18 years of age is                    protoaescigenin5
not recommended (see section 4.4 ‘Special
                                                              b) In semi-solid dosage forms: amount
warnings and precautions for use’).
                                                                   equivalent to 20% herbal preparation
Duration of use
                                                              c)   In semi-solid dosage forms: amount
At least 4 weeks of treatment may be required                      equivalent to 3.2% herbal preparation
before any beneficial effect is observed.
                                                              d) In semi-solid dosage forms: amount
Long-term use is possible in consultation with a                   equivalent to 0.85% herbal preparation
doctor.
                                                              e) In semi-solid dosage forms: amount
Method of administration                                           equivalent to 3.8% herbal preparation

Oral use                                                      f)   In semi-solid dosage forms: amount
                                                                   equivalent to 1.6% herbal preparation

                                                              For all preparations a)-f):

                                                              Single dose: Apply a thin layer on the affected
                                                              area

                                                              Daily dose: 1-3 times.

                                                              Herbal preparations g)-i)

                                                              Adults and elderly

                                                              g) Single dose: 300 mg liquid extract 2 times
                                                                   daily

                                                              Daily dose: 600 mg

                                                              h) Single dose: 154 mg 3-4 times daily

                                                              Daily dose: 462-616 mg daily

                                                              i)   Single dose: 99 mg dry extract 2 times daily

                                                              Daily dose: 198 mg

                                                              For all preparations a)-i):

                                                              There is no relevant use in children under 12

5
  Previously declared as 50 mg triterpene glycosides calculated as aescin (photometric method) with reference to the
superseded version of the Ph. Eur. monograph 1829.


European Union herbal monograph on Aesculus hippocastanum L., semen
EMA/HMPC/638242/2018                                                                                              Page 5/9
Well-established use                                          Traditional use

                                                              years of age.

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

                                                              Indication 2)

                                                              Herbal preparation a)-b)

                                                              Adolescents, adults and elderly

                                                              a) In semi-solid dosage forms: herbal
                                                                   preparation in an amount equivalent to
                                                                   approx. 0.4% triterpene glycosides, calculated
                                                                   as protoaescigenin6

                                                              b) In semi-solid dosage forms: amount
                                                                   equivalent to 20% herbal preparation

                                                              For preparation a)-b)

                                                              Single dose: Apply a thin layer on the affected
                                                              area

                                                              Daily dose: 1-3 times

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

                                                              Method of administration

                                                              Herbal preparation a)-f): Cutaneous use

                                                              Herbal preparation g)-i): Oral use




6
  Previously declared as 1% triterpene glycosides calculated as aescin (photometric method) with reference to the
superseded version of the Ph.Eur. monograph 1829.


European Union herbal monograph on Aesculus hippocastanum L., semen
EMA/HMPC/638242/2018                                                                                                Page 6/9

Contraindications

4.3. Contraindications

Well-established use                                         Traditional use

Hypersensitivity to the active substance.                    Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

If there is inflammation of the skin,                         If symptoms worsen or signs of skin infections
thrombophlebitis or subcutaneous induration,                  occur during the use of the medicinal product, a
severe pain, ulcers, sudden swelling of one or                doctor or a qualified health care practitioner
both legs, cardiac or renal insufficiency, a doctor           should be consulted.
should be consulted.
                                                              Cutaneous use:
If the symptoms worsen or signs of skin infections
                                                              The product should not be used on broken skin,
occur during the use of the medicinal product, a
                                                              around the eyes or on mucous membranes.
doctor or a pharmacist should be consulted.
                                                              Indication 1)
The use is not recommended in adolescents under
18 years of age due to a lack of data on safety               If there is inflammation of the skin,
and efficacy.                                                 thrombophlebitis or subcutaneous induration,
                                                              severe pain, ulcers, sudden swelling of one or
                                                              both legs, cardiac or renal insufficiency, a doctor
                                                              should be consulted.

                                                              The use in adolescents under 18 years of age is
                                                              not recommended because of concerns requiring
                                                              medical advice.

                                                              Indication 2)

                                                              In the absence of sufficient safety data, the use in
                                                              children below 12 years of age is not
                                                              recommended.

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                                                 None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

Gastrointestinal complaints, headache, vertigo,               Cutaneous use: Hypersensitivity reactions of the
itching and allergic reactions have been reported.            skin (itching and erythema) have been reported.
The frequency is not known.                                   The frequency is not known.

If other adverse reactions not mentioned above                Oral use: Gastrointestinal complaints, headache,
occur, a doctor or a pharmacist should be                     vertigo, itching and allergic reactions have been
consulted.                                                    reported. The frequency is not known.

                                                              Cutaneous and oral 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 composition 1,2
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
                                                                Hypericum perforatum L., herba (St. John’s wort)
Hypericum perforatum L., herba (St. John’s wort)
                                                                i) Herbal substance
i) Herbal substance
                                                                Not applicable.
Not applicable.
                                                                ii) Herbal preparations
ii) Herbal preparations 3
                                                                a) Dry extract (DER 4-7:1), extraction solvent
a) Dry extract (DER 3-7:1), extraction solvent                  ethanol 38% (m/m) = 45% V/V
methanol 80% V/V
                                                                b) Liquid extract (DER 1:4-20), extraction solvent
b) Dry extract (DER 3-6:1), extraction solvent                  vegetable oil
ethanol 80% V/V
                                                                c) Liquid extract (DER 1:13), extraction solvent
c) Dry extract (DER 2.5-8:1), extraction solvent                maize oil or other suitable vegetable oil
ethanol 50-68% V/V 4
                                                                d) Tincture (ratio herbal substance: extraction
                                                                solvent 1:5), extraction solvent ethanol 50-70%
                                                                V/V

                                                                e) Tincture (ratio herbal substance: extraction
                                                                solvent 1:10), extraction solvent ethanol 45-50%
                                                                V/V

                                                                f) Liquid extract (DER 1:2-7), extraction solvent
                                                                ethanol 50% V/V4

                                                                g) Liquid extract from fresh herb (DER 1:1),
                                                                extraction solvent ethanol 96% V/V

                                                                h) Expressed juice from the fresh herb (DER
                                                                1:0.5-0.9)

                                                                i) Stabilised expressed juice from fresh herb: The
                                                                fresh herb is first stabilised over a boiling ethanol,
                                                                then pressed and adjusted with water to a DER of

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

quality guidance.
2 The material complies with the Ph. Eur. monograph (ref. 01/2017: 1438)
3 The herbal preparations comply with the Ph. Eur. monograph (ref. 01/2017: 1874)
4 A narrow range of the DER to be specified for each individual medicinal product.



European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                                  Page 3/14
Well-established use                                          Traditional use

                                                              1:1.

                                                              j) Comminuted herbal substance

                                                              k) Powdered herbal substance



3. Pharmaceutical form
 Well-established use                                          Traditional use

 Herbal preparation in solid dosage forms for oral             Comminuted herbal substance as herbal tea for
 use.                                                          oral use.

 The pharmaceutical form should be described by                Comminuted herbal substance for infusion
 the European Pharmacopoeia full standard term.                preparation for cutaneous use.

                                                               Herbal preparations a), k) in solid dosage forms
                                                               for oral use.

                                                               Herbal preparations b), c), d), e), f), g), h), i) in
                                                               liquid dosage forms for oral use.

                                                               Herbal preparations b), e), f) in liquid or semi-
                                                               solid dosage forms 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)                                                 Indication 1)

 Herbal preparations a), b):                                   Herbal preparations a), c), d), e), f), g), h), j), k):

 Herbal medicinal product for the treatment of mild            Traditional herbal medicinal product for the relief
 to moderate depressive episodes.                              of temporary mental exhaustion.

 Indication 2)                                                 Indication 2)

 Herbal preparation c):                                        Herbal preparations b), d), e), j):

 Herbal medicinal product for the short-term                   Traditional herbal medicinal product for the
 treatment of symptoms in mild depressive                      symptomatic treatment of minor inflammations of
 disorders.                                                    the skin (such as sunburn) and as an aid in
                                                               healing of minor wounds.

                                                               Indication 3)

                                                               Herbal preparation i), j):

                                                               Traditional herbal medicinal product for the


European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                          Page 4/14
 Well-established use                                          Traditional use

                                                               symptomatic relief of mild gastrointestinal
                                                               discomfort.

                                                               Indication 4)

                                                               Herbal preparation j):

                                                               Traditional herbal medicinal product for the
                                                               supportive treatment of nervous restlessness and
                                                               associated with difficulties in falling asleep.

                                                               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                                                      Posology

 Adults and elderly                                            Indication 1)

 Herbal preparation a):                                        Adults and Elderly

          Single dose: 300-600 mg                              Herbal preparation a)
          Dosage frequency: 1-3 times daily
                                                                     Single dose: 60-180 mg
          Daily dose: 600-1800 mg
                                                                     Dosage frequency: 2-3 times daily
 Herbal preparation b):                                              Daily dose: 180 - 360 mg

          Single dose: 900 mg                                  Herbal preparation c)
          Dosage frequency: 1 single daily dose
                                                                     Single dose: 200 mg
          Daily dose: 900 mg
                                                                     Dosage frequency: 3 times daily
 Herbal preparation c):                                              Daily dose: 600 mg

          Single dose: 600 mg or 612 mg                        Herbal preparation d)
          Dosage frequency: 1 single daily dose
                                                                     Single dose: 1-1.5 ml
          Daily dose: 600 mg or 612 mg
                                                                     Dosage frequency: 3 times daily
          or                                                         Daily dose: 3-4.5 ml

          Single dose: 250-600 mg                              Herbal preparation e)
          Dosage frequency: 2-3 times daily
                                                                     Single dose: 2-4 ml
          Daily dose: 500-1200 mg
                                                                     Dosage frequency: 3 times daily
 Children, adolescents                                               Daily dose: 6-12 ml

 The use in children and adolescents under 18                  Herbal preparation f)
 years of age is not recommended (see section 4.4
                                                                     Single dose: 0.8-1.5 ml
 ‘Special warnings and precautions for use’).
                                                                     Dosage frequency: 3 times daily



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 Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                              Page 5/14
 Well-established use                                          Traditional use

 Duration of use                                                    Daily dose: 2.4-4.5 ml

 Indication 1)                                                 Herbal preparation g)

 The onset of the effect can be expected within 4                   Single dose: 5ml
 weeks of treatment. If the symptoms persist                        Dosage frequency: 4 times daily
 during the use of the medicinal product, a doctor                  Daily dose: 20 ml
 should be consulted.
                                                               Herbal preparation h)
 Indication 2)
                                                                    Single dose: 10 – 20 ml
 Six weeks.                                                         Dosage frequency: 1-3 times daily
                                                                    Daily dose: 10-30 ml
 The onset of the effect can be expected within 4
 weeks of treatment. If the symptoms persist                   Herbal preparation j)
 during the use of the medicinal product, a doctor
                                                                    Herbal tea: 1.5 - 2 g of the comminuted
 should be consulted.
                                                                    herbal substance in 150 ml of boiling water
 Method of administration                                           as a herbal infusion, 2-3 times daily
                                                                    Daily dose: 3-6 g
 Oral use.
                                                               Herbal preparation k)

                                                                    Single dose: 300 – 500 mg
                                                                    Dosage frequency: 2-3 times daily
                                                                    Daily dose: 900 – 1000 mg

                                                               Children, adolescents

                                                               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, elderly

                                                               Herbal preparation b), e), f):

                                                               Cutaneous administration of the undiluted herbal
                                                               preparation

                                                               Herbal preparation j):

                                                               Comminuted herbal preparation for infusion
                                                               preparation for cutaneous use: 2 g of the
                                                               comminuted herbal substance in 150 ml of water,
                                                               several times daily as washing or impregnated
                                                               dressing

                                                               Children

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

                                                               Indication 3)


European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                          Page 6/14
 Well-established use                                          Traditional use

                                                               Adults, elderly

                                                               Herbal preparation i)

                                                                    Single dose: 2.5 ml
                                                                    Dosage frequency: 3 times daily
                                                                    Daily dose: 7.5 ml

                                                               Herbal preparation j):

                                                                    Herbal tea: 2 g of the comminuted herbal
                                                                    substance in 150 ml of boiling water as a
                                                                    herbal infusion, 2 times daily

                                                               Children, adolescents

                                                               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 4)

                                                               Adults, elderly

                                                               Herbal preparation j):

                                                                    Herbal tea: 2-3 g of the comminuted herbal
                                                                    substance in 150 ml of boiling water as a
                                                                    herbal infusion, 2 times daily

                                                               Children, adolescents

                                                               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

                                                               Indications 1) and 4)

                                                               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 2) and 3)

                                                               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), 3) and 4)



European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                       Page 7/14
 Well-established use                                          Traditional use

                                                               Oral use.

                                                               Indication 2)

                                                               Cutaneous use.

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

 Hypersensitivity to the active substance.                     Daily dose of hyperforin ≤ 1 mg:

 Concomitant use with coumarin-type                            Hypersensitivity to the active substance.
 anticoagulants, cyclosporine, everolimus,
                                                               Daily dose of hyperforin > 1 mg:
 sirolimus, tacrolimus for systemic use,
 fosamprenavir, indinavir and other protease                   Hypersensitivity to the active substance.
 inhibitors, nucleoside reverse transcriptase
                                                               Concomitant use with coumarin-type
 inhibitors, irinotecan, imatinib and other cytostatic
                                                               anticoagulants, cyclosporine, everolimus,
 agents metabolised by CYP3A4, CYP2B6, CYP2C9,
                                                               sirolimus, tacrolimus for systemic use,
 CYP2C19 or transported by P-glycoprotein (see
                                                               fosamprenavir, indinavir and other protease
 section 4.5 ‘Interactions with other medicinal
                                                               inhibitors, nucleoside reverse transcriptase
 products and other forms of interaction’).
                                                               inhibitors, irinotecan, imatinib and other cytostatic
                                                               agents metabolised by CYP3A4, CYP2B6, CYP2C9,
                                                               CYP2C19 or transported by P-glycoprotein (see
                                                               section 4.5 ‘Interactions with other medicinal
                                                               products and other forms of interaction’).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                          Traditional use

 Indications 1) and 2)                                         Indications 1), 3) and 4)

 During the treatment intense UV-exposure should               During the treatment intense UV-exposure should
 be avoided.                                                   be avoided.

 Since no sufficient data are available, the use in            Since no sufficient data are available the use in
 children and adolescents under 18 years of age is             children and adolescents under 18 years of age is
 not recommended.                                              not recommended.

                                                               Indication 2)

                                                               During the treatment intense UV-exposure of the
                                                               respective skin areas should be avoided.

                                                               Since no data on the safe use in children are
                                                               available, the use in children under 12 years of
                                                               age is not recommended.



European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                          Page 8/14
 Well-established use                                          Traditional use

                                                               If signs of skin infections are observed, a doctor
                                                               or a qualified healthcare practitioner should be
                                                               consulted.

                                                               Indications 1) and 2)

                                                               For herbal 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 6

 Well-established use                                          Traditional use

 Patients taking other medicines on prescription               Patients taking other medicines on prescription
 are advised to consult a doctor or pharmacist                 are advised to consult a doctor or pharmacist
 before taking Hypericum.                                      before taking Hypericum.

 Pharmacokinetic interactions:                                 Pharmacokinetic interactions:

 Hyperici herba preparations induce the activity of            Indications 1), 3) and 4)
 CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P-
                                                               Daily dose of hyperforin ≤ 1 mg:
 glycoprotein. Concomitant use with coumarin-type
 anticoagulants, cyclosporine, everolimus,                     As the daily intake of hyperforin is less than 1 mg
 sirolimus, tacrolimus for systemic use,                       and of a duration of use not longer than 2 weeks
 fosamprenavir, indinavir and other protease                   no clinically relevant interactions are reported for
 inhibitors, nucleoside reverse transcriptase                  concomitantly administered drugs which are
 inhibitors, irinotecan, imatinib and other cytostatic         metabolised via CYP1A2, CYP2B6, CYP2C9,
 agents metabolised by CYP3A4, CYP2B6, CYP2C9,                 CYP2C19, CYP3A4 or transported by P-
 CYP2C19 or transported by P-glycoprotein is                   glycoprotein. Pharmacokinetic interactions with
 contraindicated (see section 4.3.                             drugs which are metabolised via other CYP-
 ‘Contraindications’).                                         enzymes have not been investigated.

 Special care should be taken in case of                       Daily dose of hyperforin > 1 mg:
 concomitant use of all drug substances the
                                                               Hyperici herba preparations induce the activity of
 metabolism of which is influenced by CYP3A4,
                                                               CYP3A4, CYP2B6, CYP2C9, CYP2C19 and P-
 CYP2B6, CYP2C9, CYP2C19 or P-glycoprotein
                                                               glycoprotein. Concomitant use with coumarin-type
 (e.g., amitriptyline, fexofenadine, alprazolam,
                                                               anticoagulants, cyclosporine, everolimus,
 diazepam, midazolam, methadone, simvastatin,
                                                               sirolimus, tacrolimus for systemic use,
 digoxin, finasteride), because a reduction of
                                                               fosamprenavir, indinavir and other protease
 plasma concentrations is possible.
                                                               inhibitors, nucleoside reverse transcriptase
 The reduction of plasma concentrations of                     inhibitors, irinotecan, imatinib and other cytostatic
 hormonal contraceptives may lead to increased                 agents metabolised by CYP3A4, CYP2B6, CYP2C9,
 intermenstrual bleeding and reduced safety in                 CYP2C19 or transported by P-glycoprotein is


6 For a list of drugs of which the metabolism is evidently and significantly interacted by herbal preparations of Hyperici

herba see the Assessment report EMA/HMPC/244315/2016 chapter 5.5.4. This list may be used as guidance for the product
information of individual products.

European Union herbal monograph on Hypericum perforatum L., herba
EMA/HMPC/7695/2021                                                                                               Page 9/14
 Well-established use                                          Traditional use

 birth control. Women using hormonal                           contraindicated (see section 4.3.
 contraceptives should take additional                         ‘Contraindications’).
 contraceptive measures.
                                                               Special care should be taken in case of
 Prior to elective surgery possible interactions with          concomitant use of all drug substances the
 products used during general and regional                     metabolism of which is influenced by CYP3A4,
 anaesthesia should be identified. If necessary, the           CYP2B6, CYP2C9, CYP2C19, or P-glycoprotein
 herbal medicinal product should be discontinued.              (e.g., amitriptyline, fexofenadine, alprazolam,
                                                               diazepam, midazolam, methadone, simvastatin,
 The elevated enzyme activity returns within 1
                                                               digoxin, finasteride), because a reduction of
 week after cessation to normal level.
                                                               plasma concentrations is possible.
 Pharmacodynamic interactions:
                                                               The reduction of plasma concentrations of
 Hypericum dry extract may contribute to                       hormonal contraceptives may lead to increased
 serotonergic effects when combined with                       intermenstrual bleeding and reduced safety in
 antidepressants such as serotonin reuptake                    birth control. Women using hormonal
 inhibitors (e.g. sertraline, paroxetine) or                   contraceptives should take additional
 buspirone. Very rarely undesired effects                      contraceptive measures.
 (serotonin syndrome) with autonomic
                                                               Prior to elective surgery possible interactions with
 dysfunctions (such as perspiration, tachycardia,
                                                               products used during general and regional
 diarrhoea, fever), mental alterations (such as
                                                               anaesthesia should be identified. If necessary, the
 agitation, disorientation), and motor alterations
                                                               herbal medicinal product should be discontinued.
 (such as tremor or myoclonias) can occur in
 combination with serotonin-uptake inhibitors or               The elevated enzyme activity returns within 1
 other serotonergic active substances.                         week after cessation to normal level.

                                                               Pharmacodynamic interactions:

                                                               Hyperici herba preparations may contribute to
                                                               serotonergic effects when combined with
                                                               antidepressants such as serotonin reuptake
                                                               inhibitors (e.g. sertraline, paroxetine) or
                                                               buspirone. Very rarely undesired effects
                                                               (serotonin syndrome) with autonomic
                                                               dysfunctions (such as perspiration, tachycardia,
                                                               diarrhoea, fever), mental alterations (such as
                                                               agitation, disorientation), and motor alterations
                                                               (such as tremor or myoclonias) can occur in
                                                               combination with serotonin-uptake inhibitors or
                                                               other serotonergic active substances.

                                                               Indication 2)

                                                               None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                          Traditional use

 Gastrointestinal disorders (such as nausea,                   Indications 1), 3) and 4)
 abdominal pain and diarrhoea), allergic skin
                                                               Gastrointestinal disorders (such as nausea,
 reactions, fatigue and restlessness may occur.
                                                               abdominal pain and diarrhoea), allergic skin
 The frequency is not known.
                                                               reactions, fatigue and restlessness may occur.
 Fair-skinned individuals may react with                       The frequency is not known.
 dysesthesia (e.g. tingling, sensitivity cold or pain,
                                                               Fair-skinned individuals may react with
 burning sensation) and intensified sunburn-like
                                                               dysesthesia (e.g. tingling, sensitivity cold or pain,
 symptoms under intense sunlight.
                                                               burning sensation) and intensified sunburn-like
 If other adverse reactions not mentioned above                symptoms under intense sunlight.
 occur, a doctor or a pharmacist should be
                                                               If other adverse reactions not mentioned above
 consulted.
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.

                                                               Indication 2)

                                                               Skin reactions may occur. 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 2
Well-established use                                            Traditional use

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

                                                                Juglans regia L., folium, (walnut leaf)

                                                                i) Herbal substance
                                                                   Not applicable

                                                                ii) Herbal preparations
                                                                   Comminuted herbal substance



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance for decoction
                                                                preparation 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 for the relief
                                                                of minor inflammatory conditions of the skin.

                                                                Indication 2)

                                                                Traditional herbal medicinal product used in
                                                                excessive perspiration of hands and feet.

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

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 Juglans regia L., folium
EMA/HMPC/346737/2011                                                                                                 Page 2/5
4.2. Posology and method of administration 3

Well-established use                                          Traditional use

                                                              Posology

                                                              Adults and elderly
                                                              Indication 1)

                                                              Comminuted herbal substance for decoction
                                                              preparation for cutaneous use: 4-6 g of the
                                                              comminuted herbal substance in 200 ml of boiling
                                                              water.

                                                              Apply as a impregnated dressing to the affected
                                                              areas of the skin 2 - 4 times daily.

                                                              Indication 2)

                                                              Comminuted herbal substance for decoction
                                                              preparation for cutaneous use: 4-6 g of the
                                                              comminuted herbal substance in 200 ml of boiling
                                                              water.

                                                              Apply as a impregnated dressing to the affected
                                                              areas of the skin up to 30 minutes twice 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

                                                              Not to be used for more than 1 week.

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

                                                              Method of administration

                                                              Cutaneous use.

Contraindications

4.3. Contraindications

Well-established use                                         Traditional use

                                                             Hypersensitivity to the active substance.

                                                             Open wounds and large skin injuries.




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 Juglans regia L., folium
EMA/HMPC/346737/2011                                                                                             Page 3/5

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                     Traditional use

                                                         The use temporarily stains the skin.

                                                         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.

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.




Community herbal monograph on Juglans regia L., folium
EMA/HMPC/346737/2011                                                                                  Page 4/5

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

                                                                Juniperus communis L., aetheroleum
                                                                (juniper oil)

                                                                i) Herbal substance
                                                                   Not applicable.

                                                                ii) Herbal preparations
                                                                   Essential oil obtained by steam distillation from
                                                                   the ripe, non-fermented berry cones.


3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparation in liquid dosage forms for oral
                                                                and cutaneous use.

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




1 The material complies with the Ph. Eur. monograph (ref.: 1/2008:1832).
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 Juniperus communis L., aetheroleum
EMA/HMPC/12402/2010                                                                                                  Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                         Traditional use

                                                             Oral use
                                                             Indication 1)
                                                             Traditional herbal medicinal product to increase
                                                             the amount of urine to achieve flushing of the
                                                             urinary tract as an adjuvant in minor urinary tract
                                                             complaints.
                                                             Indication 2)
                                                             Traditional herbal medicinal product for
                                                             symptomatic relief of digestive disorders such as
                                                             dyspepsia and flatulence.
                                                             Cutaneous use

                                                             Indication 3)
                                                             Traditional herbal medicinal product as adjuvant
                                                             in the relief of minor muscular and articular 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

Well-established use                                         Traditional use

                                                             Posology
                                                             Oral use

                                                             Adults and elderly
                                                             Average daily dose

                                                             60-100 mg juniper oil to be taken in 1-3 doses.

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



                                                             Cutaneous use

                                                             Adolescents, adults and elderly

                                                             Bath additive 3-4 times weekly 1-1.5 g juniper oil
                                                             in full bath for 10-20 minutes at 35-38°C.

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


Community herbal monograph on Juniperus communis L., aetheroleum
EMA/HMPC/12402/2010                                                                                       Page 3/6
Well-established use                                         Traditional use

                                                             Duration of use

                                                             If 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.
                                                             Indications 1) and 2)
                                                             Severe renal disease including infectious
                                                             interstitial nephritis, pyelitis and pyelonephritis.
                                                             Indication 1)
                                                             Conditions where reduced fluid intake is
                                                             recommended (e.g. severe cardiac diseases).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                         Traditional use

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

                                                             Oral use

                                                             The use in children and adolescents under
                                                             18 years of age has not been established due to
                                                             lack of adequate data.
                                                             Indication 1)
                                                             Appropriate fluid intake is recommended.

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

                                                             The use of this product is not recommended in
                                                             case of oedema due to limited heart and kidney
                                                             function.

                                                             Cutaneous use



Community herbal monograph on Juniperus communis L., aetheroleum
EMA/HMPC/12402/2010                                                                                         Page 4/6
Well-established use                                         Traditional use

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

                                                             In cases of hypertension, a full bath should be
                                                             used with caution.

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.

                                                             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

                                                                Juniperus communis L., galbulus (pseudo-
                                                                fructus) (juniper cone berry)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

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

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

                                                                d) Soft extract (DER 1.7-1.8:1), extraction
                                                                solvent water



3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparations in liquid dosage forms for
                                                                oral 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.: 07/2019:1532).




European Union herbal monograph on Juniperus communis L., galbulus (pseudo-fructus)
EMA/HMPC/241320/2021                                                                                                Page 4/9
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                          Traditional use

                                                               Indication 1)

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

                                                               Indication 2)

                                                               Traditional herbal medicinal product used for
                                                               symptomatic relief of digestive disorders such
                                                               as dyspepsia 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

                                                               Adults and elderly

                                                               Herbal preparations

                                                               Indication 1)

                                                               Preparation a)
                                                               2.0–2.5 g of the comminuted herbal substance
                                                               in 150 ml boiling water as a herbal infusion, 1-3
                                                               times daily

                                                               Single dose: 2-2.5 g

                                                               Daily dose: 2.5-6 g

                                                               Preparation b)

                                                               SD: 2-4 ml 3 times daily

                                                               DD: 6-12 ml

                                                               Preparation c)

                                                               SD: 1-2 ml 3 times daily

                                                               DD: 3-6 ml



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 Juniperus communis L., galbulus (pseudo-fructus)
EMA/HMPC/241320/2021                                                                                            Page 5/9
 Well-established use                                          Traditional use

                                                               Preparation d)

                                                               SD: 0.57 g once daily

                                                               DD: 0.57 g

                                                               Indication 2)

                                                               Preparation a)

                                                               2.0–2.5 g of the comminuted herbal substance
                                                               in 150 ml boiling water as a herbal infusion, 1-4
                                                               times daily

                                                               SD: 2-2.5 g

                                                               DD: 2.5-10 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’).

                                                               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.

                                                               Method of administration

                                                               Oral use. To ensure an increase of the amount
                                                               of urine, adequate fluid intake is required during
                                                               treatment (see section 4.4.).

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.

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

                                                               Additional to Indication 1):



European Union herbal monograph on Juniperus communis L., galbulus (pseudo-fructus)
EMA/HMPC/241320/2021                                                                                        Page 6/9
 Well-established use                                          Traditional use

                                                               Not recommended to be used in case of severe
                                                               renal disease including infectious interstitial
                                                               nephritis, pyelitis and pyelonephritis.

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

                                                               Because adequate fluid intake is required during
                                                               treatment (see section 4.2. ‘Method of
                                                               administration’), Juniperus communis L.,
                                                               galbulus is not recommended for patients with
                                                               conditions where reduced fluid intake is advised
                                                               by a medical doctor.

                                                               For liquid 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

                                                               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 composition1,2
Well-established use                                            Traditional use

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

                                                                Lavandula angustifolia Miller, aetheroleum
                                                                (lavender oil)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Essential oil obtained by steam distillation from
                                                                the flowering tops of Lavandula angustifolia Miller



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparation in liquid dosage form for oral
                                                                use and 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 for relief of
                                                                mild symptoms of mental stress and exhaustion
                                                                and to aid sleep.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication


1 The material complies with the Ph. Eur. monograph (ref.: 07/2010:1338).
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 Lavandula angustifolia Miller, aetheroleum
EMA/HMPC/143181/2010                                                                                                 Page 2/5
Well-established use                                            Traditional use

                                                                exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                            Traditional use

                                                                Posology

                                                                Adolescents, adults and elderly

                                                                   Oral use

                                                                Daily dose3: 20–80 mg

                                                                   Use as bath additive

                                                                1 to 3 g per full bath once 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

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

                                                                Method of administration

                                                                Oral use.

                                                                Use as bath additive: recommended temperature
                                                                of bath: 35–38 °C during 10-20 minutes.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

                                                               Hypersensitivity to the active substance(s).

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

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.


3
  It is expected that for the finished product, the amount will be expressed in a number of drops. As this number depends
upon the droplet counter and the oil itself, it is up to the applicant to convert the weight in a number of drops.

Community herbal monograph on Lavandula angustifolia Miller, aetheroleum
EMA/HMPC/143181/2010                                                                                               Page 3/5
Well-established use                                            Traditional use

                                                                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 composition1,2
Well-established use                                                Traditional use

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

                                                                    Lavandula angustifolia Miller, flos (lavender
                                                                    flower)

                                                                    i) Herbal substance

                                                                    As defined in the Ph. Eur. monograph.

                                                                    ii) Herbal preparations

                                                                    a) Comminuted herbal substance

                                                                    b) Tincture (ratio of herbal substance to
                                                                    extraction solvent 1:5), extraction solvent ethanol
                                                                    50-60% (V/V)



3. Pharmaceutical form
Well-established use                                                Traditional use

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

                                                                    Herbal preparations in liquid dosage form 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.: 01/2008:1534).
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 Lavandula angustifolia Miller, flos
EMA/HMPC/734125/2010                                                                                                 Page 2/5
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                Traditional use

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

                                                                    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

                                                                    Adolescents, adults and elderly

                                                                    Herbal tea: 1-2 g of the herbal substance or
                                                                    comminuted herbal substance in 150 ml of boiling
                                                                    water as a herbal infusion 3 times daily .

                                                                    Tincture: 2-4 ml, 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

                                                                    If the symptoms persist 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(s).

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.



Community herbal monograph on Lavandula angustifolia Miller, flos
EMA/HMPC/734125/2010                                                                                               Page 3/5
Well-established use                                                Traditional use

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

                                                                    For tinctures 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

                                                                    None known.

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




Community herbal monograph on Lavandula angustifolia Miller, flos
EMA/HMPC/734125/2010                                                                                             Page 4/5

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

                                                                Glycine max (L.) Merr., lecithinum (soya-bean
                                                                lecithin)

                                                                i) Herbal substance
                                                                Not applicable

                                                                ii) Herbal preparations
                                                                Soya-bean lecithin (de-oiled phospholipids from
                                                                soya bean)



3. Pharmaceutical form
    Well-established use                                        Traditional 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.



4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Traditional herbal medicinal product for the relief
                                                                of temporary fatigue and sensation of weakness.

                                                                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
  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.


European Union herbal monograph on Glycine max (L.) Merr., lecithinum
EMA/HMPC/220599/2016                                                                                                 Page 2/5
4.2. Posology and method of administration

 Well-established use                                           Traditional use

                                                                Posology
                                                                Adolescents:
                                                                Single dose: 750 mg, 2 times daily
                                                                Adults and elderly

                                                                Single dose: 750 - 2700 mg, 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
                                                                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

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance, soya,
                                                                peanut and to other plants of the Fabaceae
                                                                (legume) family and to birch pollen.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                           Traditional use

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

                                                                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




European Union herbal monograph on Glycine max (L.) Merr., lecithinum
EMA/HMPC/220599/2016                                                                                         Page 3/5

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                Allergic reactions including severe anaphylaxis
                                                                and angioedema have been reported. The
                                                                frequency is not known.

                                                                Skin reactions like pruritus, dermatitis,
                                                                exanthema and urticaria have been reported.
                                                                The frequency is not known.

                                                                Gastrointestinal disorders like stomach
                                                                discomfort and diarrhoea 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

                                                                Leonurus cardiaca L., herba (motherwort)

                                                                i) Herbal substance

                                                                   Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Powdered herbal substance

                                                                c) Tincture (ratio of herbal substance to extraction
                                                                   solvent 1:5), extraction solvent ethanol 70%
                                                                   V/V

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

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



3. Pharmaceutical form
Well-established use                                           Traditional use

                                                               Tinctures and liquid extract in liquid dosage forms
                                                               for oral use.

                                                               Powdered herbal substance for oral use.

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.


1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1833)
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 Leonurus cardiaca L., herba
EMA/HMPC/127428/2010                                                                                               Page 2/6
Well-established use                                        Traditional 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 to
                                                            relieve symptoms of nervous tension.

                                                            Indication 2)

                                                            Traditional herbal medicinal product used to
                                                            relieve symptoms of nervous cardiac complaints
                                                            such as palpitations, after serious conditions have
                                                            been excluded by a medical doctor.

                                                            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

                                                            a) Comminuted herbal substance for tea
                                                              preparation:
                                                              single dose 1.5 to 4.5 g, daily dose 3 to 10 g.

                                                            b) Powdered herbal substance:
                                                              single dose 150 mg, 1-3 times per day.

                                                            c) Tincture 1:5, ethanol 70% V/V:
                                                              single dose 0.5- 1.0 g, 3-4 times per day.

                                                            d) Tincture 1:5, ethanol 45% V/V:
                                                              single dose 2-6 ml, 3 times per day.

                                                            e) Liquid extract:
                                                              single dose 2-4 ml, 3 times per day.

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




Community herbal monograph on Leonurus cardiaca L., herba
EMA/HMPC/127428/2010                                                                                      Page 3/6
Well-established use                                        Traditional use

                                                            Duration of use

                                                            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

                                                            Oral use.

Contraindications

4.3. Contraindications

Well-established use                                        Traditional use

                                                            Hypersensitivity to the active substance.

                                                            Not to be used in pregnancy.

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

                                                            Tinctures, liquid extract: 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

                                                            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

                                                                  Levisticum officinale Koch, radix (lovage 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.




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.: 01/2013:1233).

Community herbal monograph on Levisticum officinale Koch, radix
EMA/HMPC/524621/2011                                                                                                 Page 2/5
4.2. Posology and method of administration 3

Well-established use                                              Traditional use

                                                                  Posology

                                                                  Adults and elderly

                                                                  Herbal tea

                                                                  Single dose: 2 - 3 g of comminuted herbal
                                                                  substance in 150 ml of boiling water as a herbal
                                                                  infusion, twice daily.

                                                                  Average daily dose: 4 - 6 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’).

                                                                  Duration of use

                                                                  Not to be used for more than 2 - 4 weeks.

                                                                  If the symptoms persist 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 and to
                                                                  other plants of the Apiaceae (Umbelliferae)
                                                                  family or to anethole.

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 is not recommended because of
                                                                  concerns requiring medical advice.

                                                                  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.




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 Levisticum officinale Koch, radix
EMA/HMPC/524621/2011                                                                                             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 1,2
Well-established use                                                Traditional use

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

                                                                    Cetraria islandica (L.) Acharius s.l., thallus,
                                                                    (Iceland moss)

                                                                    i) Herbal substance

                                                                    Not applicable.

                                                                    ii) Herbal preparations

                                                                    a) Comminuted herbal substance

                                                                    b) Soft extract (DER 2-4:1), extraction solvent
                                                                         water

                                                                    c)   Soft extract (DER 0.4-0.8:1), extraction
                                                                         solvent water

                                                                    d) Tincture (ratio of herbal substance to
                                                                         extraction solvent 1:5), extraction solvent
                                                                         ethanol 40% V/V



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 or oromucosal 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.: 07/2010:1439)



European Union herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus
EMA/HMPC/678891/2013                                                                                                  Page 2/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                Traditional use

                                                                    Indication 1)

                                                                    Traditional herbal medicinal product used as a
                                                                    demulcent for the symptomatic treatment of oral
                                                                    or pharyngeal irritation and associated dry cough.

                                                                    Indication 2)

                                                                    Traditional herbal medicinal product used in
                                                                    temporary loss of appetite.

                                                                    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

                                                                    Oral use

                                                                    a) Comminuted herbal substance

                                                                    Indication 1)
                                                                    Adolescents, adults and elderly
                                                                    Herbal tea: 1.5 g of the comminuted herbal
                                                                    substance in 150 ml of boiling water as a herbal
                                                                    infusion or as a macerate 3 to 4 times daily
                                                                    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’).


                                                                    Indication 2)
                                                                    Adults and elderly
                                                                    Herbal tea: 1–2 g of the comminuted herbal
                                                                    substance in 150 ml of water as an infusion or
                                                                    decoction 3 times daily
                                                                    Daily dose: 4-6 g

                                                                    The use in children and adolescents under 18
                                                                    years of age is not recommended (see section 4.4

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 Cetraria islandica (L.) Acharius s.l., thallus
EMA/HMPC/678891/2013                                                                                               Page 3/7
Well-established use                                                Traditional use

                                                                    ‘Special warnings and precautions for use’).

                                                                    d) Tincture

                                                                    Indication 1) and 2)
                                                                    Adults and elderly

                                                                    Single dose: 1-1.5 ml 3 times daily
                                                                    Daily dose: 3-4.5 ml

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

                                                                    Oromucosal use

                                                                    b) Soft extract (DER 2-4:1)

                                                                    Indication 1)
                                                                    Adolescents, adults and elderly
                                                                    Single dose: 100-200 mg several times daily
                                                                    Daily dose: 2 g

                                                                    Children 6-12 years of age
                                                                    Single dose: 100 mg 4 to 6 times daily
                                                                    Daily dose: 400 to 600 mg

                                                                    The use in children under 6 years of age is not
                                                                    recommended (see section 4.4 ‘Special warnings
                                                                    and precautions for use’).

                                                                    c) Soft extract (DER 0.4-0.8:1)

                                                                    Indication 1)
                                                                    Adolescents, adults and elderly
                                                                    Single dose: 80-160 mg several times daily
                                                                    Daily dose: 0.8-1.6 g

                                                                    Children 6-12 years of age
                                                                    Single dose: 80 mg 4 to 6 times daily
                                                                    Daily dose: 320 to 480 mg

                                                                    The use in children under 6 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 one week


European Union herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus
EMA/HMPC/678891/2013                                                                                             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

                                                                    Preparations a) and d)
                                                                    Oral use

                                                                    Preparations b) and c)
                                                                    Oromucosal use

                                                                    The macerate should be used immediately after
                                                                    preparation.

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

                                                                    Preparation a)

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

                                                                    Preparations b) and c)

                                                                    The use in children under 6 years of age is not
                                                                    recommended because of the pharmaceutical
                                                                    form (solid dosage form).

                                                                    Preparation d)

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

                                                                    Indication 2)




European Union herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus
EMA/HMPC/678891/2013                                                                                             Page 5/7
Well-established use                                                Traditional use

                                                                    Preparations a) and d)

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

                                                                    Indications 1) and 2)

                                                                    Absorption of concomitantly administered
                                                                    medicines may be delayed. As a precautionary
                                                                    measure, the product should not be taken ½ to 1
                                                                    hour before or after intake of other medicinal
                                                                    products. For tinctures 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

                                                                    None known.




European Union herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus
EMA/HMPC/678891/2013                                                                                             Page 6/7
Well-established use                                                Traditional use

                                                                    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 marketing authorisation                      With regard to the registration application of
application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
2001/83/EC as amended                                           amended
Linum usitatissimum L., semen (linseed)                         Linum usitatissimum L., semen (linseed)

i) Herbal substance                                             i) Herbal substance
   As defined in the Ph. Eur. monograph                            As defined in the Ph. Eur. monograph

                                                                ii) Herbal preparations
ii) Herbal preparations
                                                                   not applicable
    not applicable


3. Pharmaceutical form
Well-established use                                            Traditional use

Herbal substance for oral use.                                  Herbal substance for oral use.

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



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

Herbal medicinal product for the treatment of                   Traditional herbal medicinal product used as a
habitual constipation or in conditions in which                 demulcent preparation for the symptomatic relief
easy defaecation with soft stool is desirable.                  of mild gastrointestinal discomfort.

                                                                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.: 0095).

European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                                 Page 3/8
4.2. Posology and method of administration

Well-established use                                          Traditional use

Posology                                                      Posology

Adolescents, adults and elderly                               Adolescents, adults and elderly

Single dose                                                   Single dose

10 - 15 g,                                                    5 – 10 g in 250 ml water

Daily dose: 2 - 3 times daily                                 Daily dose: up to three times during the day

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

Duration of use                                               Duration of use

If the constipation does not resolve within 3 days,           If the symptoms persist for longer than 1 week
a doctor or a pharmacist should be consulted.                 during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
Method of administration
                                                              consulted.
Oral use.
                                                              Method of administration
Take 10 - 15 g seeds with 150 ml water, milk,
                                                              Oral use.
fruit juice or similar aqueous liquid 2 - 3 times
daily; then maintain adequate fluid intake. The               For a mucilaginous preparation, soak 5 - 10 g
product should be taken during the day at least ½             whole or broken seeds in 250 ml water for at least
to 1 hour before or after intake of other                     <x min> and take this half an hour before eating.
medicines. The effect starts 12 - 24 hours later.             At the time of consumption the process of swelling
                                                              has to be accomplished [length has to be specified
Warning: not to be taken immediately prior to
                                                              for the individual product]. The mucilaginous
bedtime.
                                                              preparations may be consumed with or without
                                                              the seeds.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

Hypersensitivity to the active substance.                     Hypersensitivity to the active substance.

Linseed should not be used by patients with a                 This product should not be taken by patients,
sudden change in bowel habit that persists for                who have difficulty in swallowing or any throat
more than 2 weeks, undiagnosed rectal bleeding                problems.
and failure to defaecate following the use of a
laxative.

Linseed should also not be used by patients
suffering from abnormal constrictions in the
gastro-intestinal tract, with diseases of the
oesophagus and cardia or existing intestinal
blockage (ileus), paralysis (ileus) of the intestine
or megacolon.


European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                       Page 4/8
Well-established use                                          Traditional use

This product should not be taken by patients, who
have difficulty swallowing or any throat problems.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

The use is not recommended in children under 12               The use in children under 12 years of age has not
years due to insufficient data on safety and                  been established due to lack of adequate data.
efficacy.
                                                              The treatment of debilitated patients and elderly
If abdominal pain occurs or in cases of any                   should be supervised.
irregularity of frequency of faeces, the use of
                                                              Investigations in healthy women suggest that long
linseed should be discontinued and medical advice
                                                              term use of linseed may have an oestrogenic
must be sought.
                                                              effect, and its use is therefore not recommended
Taking this herbal substance without adequate                 in women with hormonally dependent tumours.
fluid, may cause it to swell and block the throat or
oesophagus and may cause choking. Intestinal
obstruction may occur if adequate fluid intake is
not maintained. If experiencing chest pain,
vomiting, or difficulty in swallowing or breathing
after taking this herbal substance, immediate
medical attention should be sought.

The treatment of debilitated patients and elderly
should be supervised.

Investigations in healthy women suggest that long
term use of linseed may have an oestrogenic
effect, and its use is therefore not recommended
in women with hormonally dependent tumours.

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

Enteral absorption of concomitantly administered              Enteral absorption of concomitantly administered
medicines may be delayed by bulk forming                      medicines may be delayed by a demulcent
laxatives such as linseed.                                    preparation of linseed.

For this reason the product should be taken at                For this reason the product should not be taken ½
least ½ to 1 hour before or after intake of other             to 1 hour before or after intake of other medicinal
medicinal products.                                           products.

In order to decrease the risk of gastrointestinal
obstruction (ileus), linseed should be used
together with medicinal products known to inhibit
peristaltic movement (e.g. opioids, loperamide)
only under medical supervision.


European Union herbal monograph on Linum usitatissimum L., semen
EMA/HMPC/377675/2014                                                                                      Page 5/8

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

Meteorism, occurring with the use of the product,             Meteorism, occurring with the use of the product,
is common.                                                    is common.

Reactions of hypersensitivity including                       Reactions of hypersensitivity including
anaphylaxis-like reactions may occur very rarely.             anaphylaxis-like reactions may occur very rarely.

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

                                                                    Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.;
                                                                    Glycyrrhiza uralensis Fisch., radix (liquorice root)

                                                                    i) Herbal substance

                                                                    Not applicable.

                                                                    ii) Herbal preparations

                                                                    a) Comminuted herbal substance

                                                                    b) Soft extract (DER 1:0.4-0.5), extraction
                                                                          solvent water

                                                                    c)    Soft extract (DER 3:1), extraction solvent
                                                                          water



3. Pharmaceutical form
 Well-established use                                               Traditional use

                                                                    Comminuted herbal substance as herbal tea for
                                                                    oral use.

                                                                    Herbal preparations in liquid 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.: 01/2012:0277).




European Union herbal monograph on Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., radix
EMA/HMPC/108399/2024                                                                                                      Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                             Traditional use

                                                                     Indication 1)

                                                                     Traditional herbal medicinal product for the relief
                                                                     of digestive symptoms including burning
                                                                     sensation and dyspepsia.

                                                                     Indication 2)

                                                                     Traditional herbal medicinal product used as an
                                                                     expectorant in cough associated with cold.

                                                                     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 administration4

    Well-established use                                             Traditional use

                                                                     Posology

                                                                     Indication 1)

                                                                     Adults and elderly

                                                                     a) Comminuted herbal substance

                                                                     Herbal tea: 1.5 - 2 g of comminuted herbal
                                                                     substance in 150 ml of boiling water as an herbal
                                                                     infusion or decoction, 2 to 4 times daily.

                                                                     Take one cup after meals.

                                                                     Daily dose: 3 – 8 g.

                                                                     b) Soft extract (DER 1:0.4-0.5)

                                                                     Single dose: 32 mg, 2-3 times daily.

                                                                     Daily dose: 64 – 96 mg (max 160 mg daily).

                                                                     Indication 2)

                                                                     Adults and elderly

                                                                     a) Comminuted herbal substance

                                                                     Herbal tea: 1.5 g – 4.5 g of comminuted herbal
                                                                     substance in 150 ml of boiling water as an herbal
                                                                     infusion or decoction, 2-3 times daily.

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 Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., radix
EMA/HMPC/108399/2024                                                                                                      Page 4/8
 Well-established use                                                Traditional use

                                                                     Daily dose: 3 – 13.5 g.

                                                                     c) Soft extract (DER 3:1)

                                                                     Single dose: 1.2-1.5 g, 3-4 times daily.

                                                                     Daily dose: 3.6 – 6 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’).

                                                                     Duration of use

                                                                     Indication 1)

                                                                     Not to be used for more than 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.

                                                                     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

                                                                     Oral 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

                                                                     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.

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

                                                                     Patients taking liquorice medication should not



European Union herbal monograph on Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., radix
EMA/HMPC/108399/2024                                                                                                      Page 5/8
 Well-established use                                                Traditional use

                                                                     take other liquorice containing products as
                                                                     serious adverse events may occur such as water
                                                                     retention, hypokalaemia, hypertension, cardiac
                                                                     rhythm disorders.

                                                                     Liquorice medication is not recommended in
                                                                     patients affected by hypertension, kidney
                                                                     diseases, liver or cardiovascular disorders or
                                                                     hypokalaemia, as they are more sensitive to the
                                                                     adverse effects of liquorice.

                                                                     Concomitant use with diuretics, cardiac
                                                                     glycosides, corticosteroids, stimulant laxatives or
                                                                     other medications, which may aggravate
                                                                     electrolyte imbalance, is not recommended (see
                                                                     section 4.5).

                                                                     Caution is advised when liquorice is taken
                                                                     concomitantly with drugs known to be substrate
                                                                     of CYP3A4 (see section 4.5).

                                                                     Indication 2)

                                                                     If dyspnoea, fever or purulent sputum occurs, 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

                                                                     Liquorice root may counteract antihypertensive
                                                                     action of prescribed medications.

                                                                     Not to be used concomitantly with diuretics,
                                                                     cardiac glycosides, corticosteroids, stimulant
                                                                     laxatives or other medications which may
                                                                     aggravate electrolyte imbalance (see section with
                                                                     4.4).

                                                                     Liquorice root preparations might affect the
                                                                     activity of CYP3A4. Clinical studies have shown
                                                                     that the oral intake of 300 mg/day of glycyrrhizin
                                                                     for 14 days can modestly decrease the systemic
                                                                     exposure to drugs metabolised by CYP 3A4
                                                                     enzymes such as midazolam and omeprazole.
                                                                     Caution is advised in case of concomitant use of
                                                                     all drug substances the metabolism of which is
                                                                     influenced by CYP3A4.




European Union herbal monograph on Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., radix
EMA/HMPC/108399/2024                                                                                                      Page 6/8

Undesirable effects

4.8. Undesirable effects

 Well-established use                                                Traditional use

                                                                     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

                                                                Humulus lupulus L., flos (hop strobile)

                                                                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% v/v

                                                                d) Liquid extract (DER 1:10) extraction solvent
                                                                     sweet wine

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5) extraction solvent
                                                                     ethanol 60% v/v

                                                                f)   Dry extract (DER 4-5:1) extraction solvent
                                                                     methanol 50% v/v



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 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.: 1/2011:1222)


Community herbal monograph on Humulus lupulus L., flos
EMA/HMPC/682384/2013                                                                                                  Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                         Traditional use

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



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



4.2. Posology and method of administration 3

Well-established use                                         Traditional use


                                                             Posology

                                                             Adolescents, adults, elderly
                                                             In mental stress

                                                             Single dose:

                                                             a) Herbal tea: 500 mg of comminuted herbal
                                                                  substance in 150-200 ml of boiling water as a
                                                                  herbal infusion, up to 4 times daily.
                                                             b) Powdered herbal substance:
                                                                  400 mg two times daily for adults and
                                                                  200 mg two times daily for adolescents.
                                                             c)   Liquid extract (1:1): 0.5-2.0 ml, up to 3 times
                                                                  daily.
                                                             d) Liquid extract (1:10): 19 g, 2-3 times daily.

                                                             e) Tincture (1:5): 1-2 ml, up to 3 times daily.

                                                             f)   Dry extract (4-5:1): 125 mg, 2-3 times daily.
                                                             To aid sleep
                                                             Single dose:

                                                             a) Herbal tea: 500-1000 mg of comminuted
                                                                  herbal substance in 150-200 ml of boiling
                                                                  water as an herbal infusion 30 - 60 min before
                                                                  bedtime.

                                                             b) Powdered herbal substance: 800–2000 mg,
                                                                  30-60 minutes before bedtime.


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 Humulus lupulus L., flos
EMA/HMPC/682384/2013                                                                                            Page 4/7
Well-established use                                     Traditional use

                                                         c)   Dry extract (4-5:1): 125-250 mg, 60 min
                                                              before bedtime.

                                                         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 two 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.
                                                         If the symptoms worsen during the use of the
                                                         medicinal product, a doctor or 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.




Community herbal monograph on Humulus lupulus L., flos
EMA/HMPC/682384/2013                                                                                 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.

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.

                                                                 Malva sylvestris L. and/or Malva neglecta Wallr.,
                                                                 folium (mallow leaf).

                                                                 i) Herbal substance

                                                                 Not applicable

                                                                 ii) Herbal preparations

                                                                 a) 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 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 used as a
                                                                 demulcent preparation for the symptomatic
                                                                 treatment of oral or pharyngeal irritation and
                                                                 associated dry cough.
                                                                 Indication 2)

                                                                 Traditional herbal medicinal product used as a


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 9th. monograph (ref.: 2391)



European Union herbal monograph on Malva sylvestris L., folium
EMA/HMPC/749510/2016                                                                                                Page 3/7
 Well-established use                                            Traditional use

                                                                 demulcent preparation for the symptomatic relief
                                                                 of mild gastrointestinal discomfort.

                                                                 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

                                                                 Indication 1)

                                                                 Adolescents, adults and elderly

                                                                 1.8 g of the comminuted herbal substance in 150
                                                                 ml of boiling water as a herbal infusion or in 150
                                                                 ml of water as a decoction 3 times daily.

                                                                 Daily dose: 5.4 g

                                                                 Indication 2)

                                                                 Adolescents, adults and elderly

                                                                 Herbal tea: 1.8 g of the comminuted herbal
                                                                 substance in 150 ml of boiling water as a herbal
                                                                 infusion or in 150 ml of water as a decoction 3
                                                                 times daily.

                                                                 Daily dose: 5.4 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

                                                                 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.

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


European Union herbal monograph on Malva sylvestris L., folium
EMA/HMPC/749510/2016                                                                                              Page 4/7
 Well-established use                                            Traditional use

                                                                 Method of administration

                                                                 Indication 1)

                                                                 Oral and oromucosal use.

                                                                 Indication 2)

                                                                 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)

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

                                                                 Indications 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.

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.

                                                                Malva sylvestris L., flos (mallow flower)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                a) 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 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 used as a
                                                                demulcent preparation for the symptomatic
                                                                treatment of oral or pharyngeal irritation and
                                                                associated dry cough.

                                                                Indication 2)



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 9th. monograph (ref.: 1541)



European Union herbal monograph on Malva sylvestris L., flos
EMA/HMPC/749511/2016                                                                                                 Page 3/7
 Well-established use                                          Traditional use

                                                               Traditional herbal medicinal product used as a
                                                               demulcent preparation for the symptomatic relief
                                                               of mild gastrointestinal discomfort.

                                                               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

                                                               Indication 1)

                                                               Adolescents, adults and elderly

                                                               1–2 g of the comminuted herbal substance in
                                                               250 ml of boiling water as a herbal infusion or in
                                                               250 ml of water as a decoction 2-3 times daily.

                                                               Average daily dose: 5 g

                                                               Indication 2)

                                                               Adolescents, adults and elderly

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

                                                               Average daily dose: 5 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

                                                               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

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


European Union herbal monograph on Malva sylvestris L., flos
EMA/HMPC/749511/2016                                                                                              Page 4/7
 Well-established use                                          Traditional use

                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Indication 1)

                                                               Oral and oromucosal use.

                                                               Indication 2)

                                                               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)

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

                                                               Indications 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.

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 2, 3
Well-established use                                            Traditional use

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

                                                                Marrubium vulgare L., herba (White Horehound)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Powdered herbal substance

                                                                c)   Expressed juice (DER 1:0.70-0.90)

                                                                d) Liquid extract (DER 1:0.9-1.1), extraction
                                                                     solvent ethanol 20-30% V/V



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 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: 1835 corrected 6.0).

Community herbal monograph on Marrubium vulgare L., herba
EMA/HMPC/604271/2012                                                                                                 Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                          Traditional use

                                                              Indication 1)
                                                              Traditional herbal medicinal product used as an
                                                              expectorant in cough associated with cold.

                                                              Indication 2)
                                                              Traditional herbal medicinal product used for
                                                              symptomatic treatment of mild dyspeptic
                                                              complaints such as bloating and flatulence.

                                                              Indication 3)
                                                              Traditional herbal medicinal product used in
                                                              temporary loss of appetite.

                                                              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

                                                              Adolescents over 12 years of age, adults and
                                                              elderly


                                                              Indications 1), 2) and 3)
                                                              a) Comminuted herbal substance
                                                              Single dose
                                                              Herbal tea: 1-2 g of the comminuted herbal
                                                              substance in 250 ml of boiling water as a herbal
                                                              infusion, 3 times daily.
                                                              Daily dose: 3-6 g

                                                              b) Powdered herbal substance
                                                              Single dose: 225-450 mg, 3 times daily
                                                              Daily dose: 675-1350 mg

                                                              c) Expressed juice
                                                              Single dose: 10-20 ml, 3 times daily
                                                              Daily dose: 30-60 ml

                                                              d) Liquid extract
                                                              Single dose: 1.5-4 ml, 3 times daily

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).

Community herbal monograph on Marrubium vulgare L., herba
EMA/HMPC/604271/2012                                                                                             Page 3/6
Well-established use                                        Traditional use

                                                            Daily dose: 4.5-12 ml

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

                                                            Method of administration

                                                            Oral use.

                                                            Indications 2) and 3)

                                                            The herbal preparations should be taken ½ hour
                                                            before meal.

Contraindications

4.3. Contraindications

Well-established use                                        Traditional use

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

                                                            Obstruction of the bile duct, cholangitis, liver
                                                            disease, ileus.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                        Traditional use

                                                            Patients with active peptic ulcer, gallstones and
                                                            any other biliary disorders should consult a doctor
                                                            before using Marrubii herba preparations.

                                                            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



Community herbal monograph on Marrubium vulgare L., herba
EMA/HMPC/604271/2012                                                                                      Page 4/6
Well-established use                                        Traditional use

                                                            care practitioner should be consulted.

                                                            For 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

                                                            None known.

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