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 1,2
Well-established use                                            Traditional use

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


                                                                Filipendula ulmaria (L.) Maxim., herba
                                                                (meadowsweet)


                                                                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 45% (V/V)



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Powdered herbal substance in solid dosage forms
                                                                for oral use.

                                                                Herbal preparation in liquid dosage form 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.: 01/2008:1868 corrected 6.0).

Community herbal monograph on Filipendula ulmaria (L.) Maxim., herba
EMA/HMPC/434881/2010                                                                                                 Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product for the
                                                                supportive treatment of common cold.

                                                                Indication 2)

                                                                Traditional herbal medicinal product for the relief
                                                                of minor 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 3

Well-established use                                            Traditional use

                                                                Posology

                                                                Indication 1)

                                                                Adults, Elderly

                                                                a) Comminuted herbal substance as herbal tea:
                                                                single dose: 1.5-6 g, as an infusion
                                                                daily dose: 2-18 g

                                                                b) Powdered herbal substance:
                                                                single dose: 250-500 mg
                                                                daily dose: 250-1500 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’).

                                                                Indication 2)

                                                                Adults, Elderly

                                                                a) Comminuted herbal substance as herbal tea:
                                                                single dose: 1.5-6 g, as an infusion
                                                                daily dose: 2-18 g

                                                                b) Powdered herbal substance:
                                                                single dose: 250-500 mg
                                                                daily dose: 250-1500 mg

                                                                c) Tincture (1:5):

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 Filipendula ulmaria (L.) Maxim., herba
EMA/HMPC/434881/2010                                                                                            Page 3/6
Well-established use                                            Traditional use

                                                                single dose: 2-4 ml
                                                                daily dose: 6-12 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’).

                                                                Duration of use

                                                                Indication 1)

                                                                The therapy should start at first signs of common
                                                                cold.

                                                                If the symptoms persist longer than 7 days during
                                                                the use of the medicinal product, a doctor or a
                                                                qualified health care practitioner should be
                                                                consulted.

                                                                Indication 2)

                                                                Not to be used for more than 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 salicylates.

                                                               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.

                                                                Concomitant use with salicylates and other
                                                                NSAIDs is not recommended without medical
                                                                advice.

                                                                Indication 1)

                                                                If fever exceeds 39°C, persists or is associated
                                                                with severe headache, or if symptoms worsen
                                                                during the use of the medicinal product, a doctor

Community herbal monograph on Filipendula ulmaria (L.) Maxim., herba
EMA/HMPC/434881/2010                                                                                           Page 4/6
Well-established use                                            Traditional use

                                                                or a qualified health care practitioner should be
                                                                consulted.

                                                                Indication 2)

                                                                The product is not intended to be used in case of
                                                                acute arthritis as this condition requires medical
                                                                advice.

                                                                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.




Community herbal monograph on Filipendula ulmaria (L.) Maxim., herba
EMA/HMPC/434881/2010                                                                                         Page 5/6

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

                                                                 Foeniculum vulgare Miller subsp. vulgare var.
                                                                 vulgare, fructus (bitter fennel)

                                                                 i) Herbal substance
                                                                 Dry fruit

                                                                 ii) Herbal preparations

                                                                 Not applicable



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal substance as herbal tea for oral use.

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



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

                                                                 Indication 1)

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




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.: 04/2013:0824).



European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus
EMA/HMPC/372841/2016                                                                                                  Page 4/9
 Well-established use                                            Traditional use

                                                                 Indication 2)

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

                                                                 Indication 3)

                                                                 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 administration 3

 Well-established use                                            Traditional use

                                                                 Posology

                                                                 Indications 1) and 3)

                                                                 Adults and adolescents

                                                                 Single dose

                                                                 Herbal tea: 1.5 g of herbal substance in 250 ml of
                                                                 boiling water (steep for 15 minutes) as a herbal
                                                                 infusion, 3 times daily.

                                                                 Daily dose: 4.5 g

                                                                 Children between 4 and 12 years of age

                                                                 Single dose

                                                                 Herbal tea: 1.0 g of the herbal substance in 100
                                                                 ml boiling water (steep for 15 minutes) as a
                                                                 herbal infusion, 3 times daily.

                                                                 Daily dose: 3.0 g

                                                                 For further information on the use in children
                                                                 between 4 and 12 years of age, see section 4.4
                                                                 ‘Special warnings and precautions for use’.

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

                                                                 See section 6 ‘Pharmaceutical particulars’ for


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 Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus
EMA/HMPC/372841/2016                                                                                                 Page 5/9
 Well-established use                                            Traditional use

                                                                 content of estragole.

                                                                 Indication 2)

                                                                 Adults and adolescents

                                                                 Single dose

                                                                 Herbal tea: 1.5 g of herbal substance in 250 ml of
                                                                 boiling water (steep for 15 minutes) as a herbal
                                                                 infusion 3 times daily.

                                                                 Daily dose: 4.5 g

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

                                                                 See section 6 ‘Pharmaceutical particulars’ for the
                                                                 content of estragole.

                                                                 Duration of use

                                                                 Indications 1), 2) and 3)

                                                                 Adults and adolescents

                                                                 Not to be taken for more than 2 weeks.

                                                                 Indications 1) and 3)

                                                                 Children between 4 and 12 years of age

                                                                 For short-term use in mild transitory symptoms
                                                                 only (less than one 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

                                                                 Oral use.

Contraindications

4.3. Contraindications

 Well-established use                                            Traditional use

                                                                 Hypersensitivity to the active substance or to
                                                                 Apiaceae (Umbelliferae) family (aniseed, caraway,
                                                                 celery, coriander and dill) or to anethole.

                                                                 Hypersensitivity to mugwort pollen, due to cross-
                                                                 reactivity with fennel.




European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus
EMA/HMPC/372841/2016                                                                                           Page 6/9

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 Indications 1) and 3)

                                                                 The use in children between 4 and 12 years of age
                                                                 is not recommended if the daily intake of
                                                                 estragole exceeds the guidance value of 1.0 µg/kg
                                                                 bw, unless justified by a risk assessment based on
                                                                 adequate safety data (see section 5.3 ‘Preclinical
                                                                 safety data’).

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

                                                                 Indication 2)

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

                                                                 If 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

                                                                 Allergic reactions to fennel, affecting the skin or
                                                                 the respiratory system 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 composition1, 2
  Well-established use                                            Traditional use

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

                                                                  Foeniculum vulgare Miller subsp. vulgare var.
                                                                  dulce (Mill.) Batt. & Trab., fructus (sweet fennel)

                                                                  i) Herbal substance
                                                                  Dry fruit

                                                                  ii) Herbal preparations

                                                                  Not applicable



 3. Pharmaceutical form
  Well-established use                                            Traditional use

                                                                  Herbal substance as herbal tea for oral use.

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



 4. Clinical particulars

 4.1. Therapeutic indications

  Well-established use                                            Traditional use

                                                                  Indication 1)

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

                                                                  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. monograph (ref.: 04/2011:0825).



European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var.
dulce (Mill.) Batt. & Trab., fructus
EMEA/HMPC/372839/2016                                                                                               Page 4/10
  Well-established use                                            Traditional use

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

                                                                  Indication 3)

                                                                  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 administration3

  Well-established use                                            Traditional use

                                                                  Posology

                                                                  Indications 1) and 3)

                                                                  Adults and adolescents

                                                                  Single dose

                                                                  Herbal tea: 1.5 g of herbal substance in 250 ml
                                                                  of boiling water (steep for 15 minutes) as a
                                                                  herbal infusion, 3 times daily.

                                                                  Daily dose: 4.5 g

                                                                  Children between 4 and 12 years of age

                                                                  Single dose

                                                                  Herbal tea: 1.0 g of the herbal substance in 100
                                                                  ml boiling water (steep for 15 minutes) as a
                                                                  herbal infusion, 3 times daily.

                                                                  Daily dose: 3.0 g

                                                                  For further information on the use in children
                                                                  between 4 and 12 years of age see section 4.4
                                                                  ‘Special warnings and precautions for use’.

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

                                                                  See section 6 ‘Pharmaceutical particulars’ for
                                                                  content of estragole.




 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 Foeniculum vulgare Miller subsp. vulgare var.
dulce (Mill.) Batt. & Trab., fructus
EMEA/HMPC/372839/2016                                                                                            Page 5/10
  Well-established use                                            Traditional use

                                                                  Indication 2)

                                                                  Adults and adolescents

                                                                  Single dose

                                                                  Herbal tea: 1.5 g of herbal substance in 250 ml
                                                                  of boiling water (steep for 15 minutes) as a
                                                                  herbal infusion 3 times daily.

                                                                  Daily dose: 4.5 g

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

                                                                  See section 6 ‘Pharmaceutical particulars’ for
                                                                  content of estragole.

                                                                  Duration of use

                                                                  Indications 1), 2) and 3)

                                                                  Adults and adolescents

                                                                  Not to be taken for more than 2 weeks.

                                                                  Indications 1) and 3)

                                                                  Children between 4 and 12 years of age

                                                                  For short-term use in mild transitory symptoms
                                                                  only (less than one 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

                                                                  Oral use.

Contraindications

 4.3. Contraindications

  Well-established use                                           Traditional use

                                                                 Hypersensitivity to the active substance or to
                                                                 Apiaceae (Umbelliferae) family (aniseed,
                                                                 caraway, celery, coriander and dill) or to
                                                                 anethole.

                                                                 Hypersensitivity to mugwort pollen, due to cross-
                                                                 reactivity with fennel.




European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var.
dulce (Mill.) Batt. & Trab., fructus
EMEA/HMPC/372839/2016                                                                                         Page 6/10

Special warnings and precautions for use

 4.4. Special warnings and precautions for use

  Well-established use                                            Traditional use

                                                                  Indications 1) and 3)

                                                                  The use in children between 4 and 12 years of
                                                                  age is not recommended if the daily intake of
                                                                  estragole exceeds the guidance value of 1.0
                                                                  µg/kg bw, unless justified by a risk assessment
                                                                  based on adequate safety data (see section 5.3
                                                                  ‘Preclinical safety data’).

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

                                                                  Indication 2)

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

                                                                  If 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

                                                                  Allergic reactions to fennel, affecting the skin or
                                                                  the respiratory system 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 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.

Rhamnus frangula L. (Frangula alnus Miller),
cortex (frangula bark)

i) Herbal substance

Not applicable

ii) Herbal preparations

Comminuted herbal substance or herbal
preparations thereof, standardised



3. Pharmaceutical form
Well-established use                                             Traditional use

Standardised comminuted herbal substance as
herbal tea for oral use.

Standardised 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

Herbal medicinal product for short-term use in


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. monographs (ref.: 0025; 1214)



European Union herbal monograph on Rhamnus frangula L., cortex
EMA/HMPC/726261/2016                                                                                               Page 3/10

                                     Classified as public by the European Medicines Agency
Well-established use                                             Traditional use

cases of occasional constipation.


4.2. Posology and method of administration 3

Well-established use                                             Traditional use

Posology

Adolescents, adults, elderly

Single dose:

Herbal preparation equivalent to 10–30 mg
hydroxyanthracene derivatives, calculated as
glucofrangulin A, to be taken once daily at night.

The correct individual dose is the smallest
required to produce a comfortable soft-formed
motion.

Herbal tea: amount of comminuted herbal
substance equivalent to not more than 30 mg
hydroxyanthracene derivatives in 150 ml of
boiling water as herbal infusion

The use in children under 12 years of age is
contraindicated (see section 4.3
Contraindications).

The pharmaceutical form must allow lower
dosages.

Duration of use

Not to be used for more than 1 week.

Usually it is sufficient to take this medicinal
product up to two to three times during that
week.

If the symptoms persist during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

See also section 4.4 Special warnings and
precautions for use.

Method of administration

Oral use




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


European Union herbal monograph on Rhamnus frangula L., cortex
EMA/HMPC/726261/2016                                                                                            Page 4/10

                                    Classified as public by the European Medicines Agency

Contraindications

4.3. Contraindications

Well-established use                                             Traditional use

Hypersensitivity to the active substance.

Cases of intestinal obstructions and stenosis,
atony, appendicitis, inflammatory bowel diseases
(e.g. Crohn’s disease, ulcerative colitis),
abdominal pain of unknown origin, severe
dehydration state with water and electrolyte
depletion.

Pregnancy and lactation (see section 4.6 and
5.3).

Children under 12 years of age.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                             Traditional use

Long-term use of stimulant laxatives should be
avoided, as use for more than a brief period of
treatment may lead to impaired function of the
intestine and dependence on laxatives. If laxatives
are needed every day the cause of the
constipation should be investigated. Frangula bark
preparations should only be used if a therapeutic
effect cannot be achieved by a change of diet or
the administration of bulk forming agents.

Patients taking cardiac glycosides, antiarrhythmic
medicinal products, medicinal products inducing
QT-prolongation, diuretics, adrenocorticosteroids
or liquorice root, have to consult a doctor before
taking frangula bark concomitantly.

Like all laxatives, frangula bark preparations
should not be taken by patients suffering from
faecal impaction and undiagnosed, acute or
persistent gastro-intestinal complaints, e.g.
abdominal pain, nausea and vomiting, unless
advised by a doctor, because these symptoms can
be signs of potential or existing intestinal blockage
(ileus).

When preparations containing frangula bark are
administered to incontinent adults, pads should be
changed more frequently to prevent extended skin
contact with faeces.
Patients with kidney disorders should be aware of



European Union herbal monograph on Rhamnus frangula L., cortex
EMA/HMPC/726261/2016                                                                        Page 5/10

                                    Classified as public by the European Medicines Agency
Well-established use                                             Traditional use

possible electrolyte imbalance.

If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

For liquid dosage forms 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

Hypokalaemia (resulting from long-term laxative
abuse) potentiates the action of cardiac glycosides
and interacts with antiarrhythmic medicinal
products.

Concomitant use with diuretics,
adrenocorticosteroids and liquorice root may
enhance loss of potassium.

Undesirable effects

4.8. Undesirable effects

Well-established use                                             Traditional use

Hypersensitivity:

Hypersensitivity reactions (pruritus, urticaria, local
or generalised exanthema) may occur.

Gastrointestinal disorders:

Frangula bark may produce abdominal pain and
spasm and passage of liquid stools, in particular in
patients with irritable colon. However, these
symptoms may also occur generally as a
consequence of individual overdosage. In such
cases dose reduction is necessary.

Furthermore, chronic use may cause pigmentation
of the intestinal mucosa (pseudomelanosis coli),
which usually recedes when the patient stops
taking the preparation.

Kidney and urinary tract symptoms:

Long term use may lead to water and electrolyte
imbalance and may result in albuminuria and
haematuria.

Yellow or red-brown (pH dependent)
discolouration of urine by metabolites, which is
not clinically significant, may occur during the
treatment.

The frequencies are not known.

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

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

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


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

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

                                                                  Fraxinus excelsior L. or Fraxinus angustifolia Vahl
                                                                  or hybrids of these 2 species or of a mixture,
                                                                  folium (ash leaf)

                                                                  i) Herbal substance

                                                                  Not applicable.

                                                                  ii) Herbal preparations

                                                                  Comminuted herbal substance



3.       Pharmaceutical form
Well-established use                                              Traditional use

                                                                  Comminuted herbal substance as herbal tea for
                                                                  oral use.

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



4.       Clinical particulars

4.1 Therapeutic indications

Well-established use                                              Traditional use

                                                                  Indication 1)

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

                                                                  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. monograph (ref.: 07/2012:1600).

Community herbal monograph on Fraxinus excelsior L. or Fraxinus angustifolia Vahl,
folium
EMA/HMPC/239271/2011                                                                                                 Page 2/6
Well-established use                                              Traditional use

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

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


4.2 Posology and method of administration3

Well-established use                                              Traditional use

                                                                  Posology

                                                                  Adults and elderly

                                                                  Average daily dose:

                                                                  Herbal tea: 20 g of the comminuted herbal
                                                                  substance in 1000 ml of water as a decoction,
                                                                  divided in 2-3 single doses.

                                                                  Herbal tea: 10-30 g of the comminuted herbal
                                                                  substance in 1000 ml of boiling water as a herbal
                                                                  infusion, divided in 2-3 single 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’).

                                                                  Duration of use

                                                                  Indication 1)

                                                                  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.

                                                                  Indication 2)

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

                                                                  Method of administration

                                                                  Oral use.




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 Fraxinus excelsior L. or Fraxinus angustifolia Vahl,
folium
EMA/HMPC/239271/2011                                                                                             Page 3/6

Contraindications

4.3 Contraindications

Well-established use                                             Traditional use

                                                                 Hypersensitivity to the active substance(s).

                                                                 Condition 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.

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

                                                                  Indication 1)

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

                                                                  Indication 2)

                                                                  If minor 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
                                                                  professional should be consulted.

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

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

                                                                Fucus vesiculosus L., thallus (bladderwrack)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Powdered herbal substance



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

                                                                Traditional herbal medicinal product used as an
                                                                adjuvant to reduced calorie diet to help weight
                                                                loss in overweight adults, after serious conditions
                                                                have been excluded by a medical doctor.

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

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.: 01/2008:1426, corrected 6.0).



Community herbal monograph on Fucus vesiculosus L., thallus
EMA/HMPC/313674/2012                                                                                                Page 3/5
Well-established use                                          Traditional use

                                                              exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                          Traditional use

                                                              Posology

                                                              Adults and Elderly

                                                              Single dose

                                                              Powdered herbal substance: 130 mg,
                                                              twice daily with a glass of water, 2 hours before
                                                              meals.

                                                              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 patients taking Fucus vesiculosus have been
                                                              unable to lose weight after 10 weeks, they should
                                                              consult a doctor or a qualified health care
                                                              practitioner.

                                                              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 and adolescents under 18
                                                              years of age is not recommended because of
                                                              concerns requiring medical advice.

                                                              Other herbal preparations containing Fucus
                                                              vesiculosus, preparations containing iodine or
                                                              medicines for the thyroid gland should not be
                                                              taken concomitantly.




Community herbal monograph on Fucus vesiculosus L., thallus
EMA/HMPC/313674/2012                                                                                        Page 4/5

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

                                                              One case report of hyperthyroidism was published
                                                              in a patient diagnosed with bipolar disorder and
                                                              under treatment with lithium.

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 as
2001/83/EC as amended                                           amended

Ginkgo biloba L., folium (Ginkgo leaf)                          Ginkgo biloba L., folium (Ginkgo leaf)

i) Herbal substance                                             i) Herbal substance

Not applicable.                                                 Not applicable.

ii) Herbal preparations                                         ii) Herbal preparations

Dry extract (DER 35-67:1), extraction solvent:                  Powdered herbal substance
acetone 60% m/m3



3. Pharmaceutical form
Well-established use                                            Traditional use

Herbal preparations in liquid or solid dosage forms             Herbal preparations in solid dosage forms for oral
for oral use.                                                   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 improvement of                 Traditional herbal medicinal product for the relief
(age-associated) cognitive impairment and of                    of heaviness of legs and the sensation of cold
quality of life in mild dementia.                               hands and feet associated with minor circulatory
                                                                disorders, after serious conditions have been
                                                                excluded by a medical doctor.


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 01/2011: 1828
3
  The herbal preparation should be in accordance with the Ph. Eur. monograph “Ginkgo dry extract, refined and quantified”
04/2008: 1827

European Union herbal monograph on Ginkgo biloba L., folium
EMA/HMPC/321097/2012                                                                                               Page 2/8
Well-established use                                          Traditional use

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


4.2. Posology and method of administration

Well-established use                                          Traditional use

Posology                                                      Posology

Adults and elderly                                            Adults and elderly
Single dose: 120-240 mg                                       Single dose: 250-360 mg
Daily dose: 240 mg                                            Daily dose: 750 mg

There is no relevant indication for children and              The use in children and adolescents under
adolescents.                                                  18 years of age is not recommended (see section
                                                              4.4 ‘Special warnings and precautions for use’).
Duration of use
                                                              Duration of use
Treatment should last for at least 8 weeks.
                                                              If the symptoms persist for more than 2 weeks, a
If there is no symptomatic improvement after
                                                              doctor or a qualified health care practitioner
3 months, or if pathological symptoms should
                                                              should be consulted.
intensify, the doctor should check whether
continuation of treatment is still justified.                 Method of administration

Method of administration                                      Oral use.

Oral use.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

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

Pregnancy (see section 4.6. ‘Fertility, pregnancy
and lactation’).

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                  The use in children and adolescents under
medicinal product, a doctor or a pharmacist                   18 years of age has not been established due to
should be consulted.                                          lack of adequate data.

In patients with a pathologically increased                   If the symptoms worsen during the use of the
bleeding tendency (haemorrhagic diathesis) and                medicinal product, a doctor or a qualified
concomitant anticoagulant and antiplatelet                    healthcare professional should be consulted.
treatment, the medicinal product should only be
used after consultation with a doctor.



European Union herbal monograph on Ginkgo biloba L., folium
EMA/HMPC/321097/2012                                                                                       Page 3/8
Well-established use                                          Traditional use

Preparations containing Ginkgo might increase
susceptibility to bleeding, the medicinal product
should be discontinued as a precaution 3 to 4
days prior to surgery.

In patients with epilepsy, onset of further seizures
– promoted by intake of Ginkgo preparations –
cannot be excluded.

Concomitant use of Ginkgo biloba containing
products and efavirenz is not recommended (see
section 4.5).

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

If the medicinal product is taken concomitantly               Ginkgo leaf may increase the effects of
with anticoagulants (e.g. phenprocoumon and                   anticoagulants such as coumarin derivatives.
warfarin) or antiplatelet drugs (e.g. clopidogrel,
acetylsalicylic acid and other non-steroidal anti-
inflammatory drugs), their effect may be
influenced.

Available studies with warfarin do not indicate that
there is an interaction between warfarin and G.
biloba products, but adequate monitoring is
advised when starting, when changing G. biloba
dose, when ending G. biloba intake or if changing
product.

An interaction study with talinolol indicates that G.
biloba may inhibit P-glycoprotein at the intestinal
level. This may give rise to increased exposure of
drugs markedly affected by P-glycoprotein in the
intestine such as dabigatran etexilate. Caution is
advised if combining G. biloba and dabigatran.

One interaction study has indicated that the Cmax
of nifedipine may be increased by G biloba. In
some individuals, increases by up to 100% were
observed resulting in dizziness and increased
severity of hot flushes.

Concomitant use of G. biloba preparations and
efavirenz is not recommended; plasma
concentrations of efavirenz may be decreased
because of induction of CYP3A4 (see also section
4.4).



European Union herbal monograph on Ginkgo biloba L., folium
EMA/HMPC/321097/2012                                                                                    Page 4/8

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

Blood and lymphatic system disorders                          Gastrointestinal disorders, headaches and allergic
Bleeding of individual organs has been reported               reactions have been reported. The frequency is
(eye, nose, cerebral and gastrointestinal                     not known.
haemorrhage). The frequency is not known.
                                                              If other adverse reactions not mentioned above
Nervous system disorders                                      occur, a doctor or a qualified health care
Very common: headache                                         practitioner should be consulted.
Common: dizziness

Gastrointestinal disorders
Common: diarrhoea, abdominal pain, nausea,
vomiting




European Union herbal monograph on Ginkgo biloba L., folium
EMA/HMPC/321097/2012                                                                                       Page 5/8
Well-established use                                          Traditional use

Immune system disorders
Hypersensitivity reactions (allergic shock) may
occur. The frequency is not known.

Skin and subcutaneous tissue disorders
Allergic skin reactions (erythema, oedema, itching
and rash) may also occur. The frequencies are not
known.

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

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

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


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

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

                                                                Panax ginseng C.A. Mey., radix (Ginseng)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                White ginseng:

                                                                a) Comminuted herbal substance

                                                                b) Powdered herbal substance

                                                                c)   Dry extract (DER 2-7:1), extraction solvent
                                                                     ethanol 34-40% V/V

                                                                d) Dry extract (DER 3-7:1), extraction
                                                                     solvent ethanol 40% V/V, containing 4%
                                                                     ginsenosides (sum of Rb1, Rb2, Rc, Rd, Re,
                                                                     Rf, Rg1, Rg2)

                                                                e) Dry extract (DER 3-7:1), extraction
                                                                     solvent ethanol 57.9% V/V (=50%
                                                                     m/m)-60% V/V

                                                                f)   Dry extract (DER 3.3-5:1), extraction
                                                                     solvent methanol 60% V/V

                                                                g) Soft extract (DER 1.7-3.2:1),
                                                                     extraction solvent ethanol 60%-70%
                                                                     V/V

                                                                h) Soft extract (DER 2-6:1), extraction
                                                                     solvent methanol 30% V/V

                                                                i)   Liquid extract (DER 1: 0.8-1.2),
                                                                     extraction solvent ethanol 30.5% V/V

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.: 1523)




European Union herbal monograph on Panax ginseng C.A.Mey., radix                                                   Page 3/10
EMA/HMPC/27744/2023
  Well-established use                                         Traditional use

                                                                    (=25% m/m) – 34% m/m
                                                               j)   Liquid extract (DER 1:11-13.6), extraction
                                                                    solvent liquor wine

                                                               Red Ginseng:

                                                               k) Powdered herbal substance

                                                               l)   Dry extract (DER 2-4.5:1), extraction
                                                                    solvent ethanol 60% V/V

                                                               m) Soft extract (DER 2.5-3.2:1), extraction
                                                                    solvent ethanol 60% V/V


3. Pharmaceutical form


  Well-established use                                         Traditional use

                                                               Comminuted herbal substance (herbal
                                                               preparation a)) as herbal tea for oral use.

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

                                                               Herbal preparations g), h), i), j), m) in liquid
                                                               dosage forms for oral use.

                                                               Herbal preparations b), c), d), e) in solid and
                                                               liquid dosage forms for oral use.

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



4. Clinical particulars

4.1. Therapeutic indications

  Well-established use                                         Traditional use

                                                               Traditional herbal medicinal product for
                                                               symptoms of asthenia such as fatigue and
                                                               weakness.

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




European Union herbal monograph on Panax ginseng C.A.Mey., radix                                             Page 4/10
EMA/HMPC/27744/2023
4.2. Posology and method of administration 3

  Well-established use                                         Traditional use

                                                               Posology

                                                               Adults and elderly

                                                               White ginseng:

                                                               a) Comminuted herbal substance:

                                                                    Herbal tea: 1000-2000 mg of the
                                                                    comminuted herbal substance in 150 ml of
                                                                    water as a decoction 2-3 times daily

                                                               b) Powdered herbal substance:

                                                                    Single dose: 250-1200 mg

                                                                    Daily dose: 600-2000 mg

                                                                    Dosage frequency: once daily (1200 mg),
                                                                    2-8 times daily
                                                               c)   Dry extract (DER 2-7:1), extraction
                                                                    solvent ethanol 34-40% V/V

                                                                    Single dose: 90-360 mg

                                                                    Daily dose: 200-670 mg

                                                                    Dosage frequency: 1-4 times daily

                                                               d) Dry extract (DER 3-7:1), extraction
                                                                    solvent ethanol 40% V/V, containing
                                                                    4% ginsenosides (sum of Rb1, Rb2, Rc,
                                                                    Rd, Re, Rf, Rg1, Rg2)

                                                                    Single dose: 40-200 mg

                                                                    Daily dose: 40-200 mg (can be
                                                                    increased up to 600 mg in the first 5
                                                                    days in special situations)

                                                                    Dosage frequency: 1-2 times daily

                                                               e) Dry extract (DER 3-7:1), extraction
                                                                    solvent ethanol 57.9 % V/V (=50%
                                                                    m/m) – 60% V/V

                                                                    Single dose: 98-360 mg

                                                                    Daily dose: 196-525 mg

                                                                    Dosage frequency: 1-4 times daily



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 Panax ginseng C.A.Mey., radix                                                Page 5/10
EMA/HMPC/27744/2023
  Well-established use                                         Traditional use

                                                               f)   Dry extract (DER 3.3-5:1), extraction
                                                                    solvent methanol 60% V/V

                                                                    Single dose: 120 mg

                                                                    Daily dose: 360 mg

                                                                    Dosage frequency: 3 times daily

                                                               g)   Soft extract (DER 1.7-3.2:1),
                                                                    extraction solvent ethanol 60%-70%
                                                                    V/V

                                                                    Single dose: 300-440 mg

                                                                    Daily dose: 440-700 mg

                                                                    Dosage frequency: once daily (440
                                                                    mg) or 2 times daily

                                                               h) Soft extract (DER 2-6:1), extraction
                                                                    solvent methanol 30% V/V

                                                                    Single dose: 219.8 mg

                                                                    Daily dose: 439.6 mg

                                                                    Dosage frequency: 2 times daily

                                                               i)   Liquid extract (DER 1:0.8-1.2),
                                                                    ethanol 30.5% V/V (=25% m/m) –
                                                                    34% m/m

                                                                    Single dose: 500 mg - 1250 mg Daily
                                                                    dose: 900 mg – 2500 mg Dosage
                                                                    frequency: 1-2 times daily

                                                               j)   Liquid extract (DER 1:11-13.6),
                                                                    extraction solvent liquor wine

                                                                    Single dose: 9.90 g

                                                                    Daily dose: 19.80 g

                                                                    Dosage frequency: 2 times daily

                                                               Red ginseng:
                                                               k) Powdered herbal substance:

                                                                    Single dose: 600 mg -1200 mg

                                                                    Daily dose: 1200 mg - 1800 mg

                                                                    Dosage frequency: 1-3 times daily

                                                               l)   Dry extract (DER 2-4.5:1), extraction
                                                                    solvent ethanol 60% V/V




European Union herbal monograph on Panax ginseng C.A.Mey., radix                                            Page 6/10
EMA/HMPC/27744/2023
  Well-established use                                         Traditional use

                                                                   Single dose: 180-500 mg

                                                                   Daily dose: 360-500 mg

                                                                   Dosage frequency: once daily (475 mg or
                                                                   500 mg) or 2 times daily

                                                               m) Soft extract (DER 2.5-3.2:1), extraction
                                                                   solvent ethanol 60% V/V

                                                                   Single dose: 440 mg

                                                                   Daily dose: 440 mg

                                                                   Dosage frequency: once 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

                                                               Duration of use up to 3 months. 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.

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.

                                                               For extracts containing ethanol, the
                                                               appropriate labelling for ethanol, taken from
                                                               the ‘Guideline on excipients in the label and



European Union herbal monograph on Panax ginseng C.A.Mey., radix                                            Page 7/10
EMA/HMPC/27744/2023
  Well-established use                                         Traditional use

                                                               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

                                                               Gastrointestinal disorders: stomach discomfort,
                                                               nausea, vomiting, diarrhoea, and constipation
                                                               have been reported. The frequency is not
                                                               known.

                                                               Immune system disorders: Hypersensitivity
                                                               reactions (urticaria, itching) have been
                                                               reported: The frequency is not known.

                                                               Nervous system disorders: Insomnia has been
                                                               reported. The frequency is not known.

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




European Union herbal monograph on Panax ginseng C.A.Mey., radix                                           Page 8/10
EMA/HMPC/27744/2023

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

                                                                  Grindelia robusta Nutt., Grindelia squarrosa
                                                                  (Pursh) Dunal, Grindelia humilis Hook. et Arn.,
                                                                  Grindelia camporum Greene, herba or a mixture
                                                                  of them (Gumweed herb)



                                                                  i) Herbal substance

                                                                  Not applicable.



                                                                  ii) Herbal preparations

                                                                  a) Comminuted herbal substance

                                                                  b) Liquid extract (DER 1:1), extraction
                                                                       solvent ethanol 22.5% V/V

                                                                  c)   Tincture (ratio of herbal substance to
                                                                       extraction solvent 1:10), extraction solvent
                                                                       ethanol 60% V/V




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 French pharmacopoeia monograph (January 1998).

Community herbal monograph on Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et
Arn., Grindelia camporum Greene, herba
EMA/HMPC/748220/2011                                                                                                   Page 2/6
3. Pharmaceutical form
Well-established use                                              Traditional use

                                                                  Herbal preparations in liquid dosage forms for oral
                                                                  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 for relief of
                                                                  cough associated with cold.

                                                                  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 3

Well-established use                                              Traditional use

                                                                  Posology

                                                                  Adults and elderly


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

                                                                  b) Liquid extract: 0.6 - 1.2 ml 3 times daily
                                                                      Daily dose: 1.8 - 3.6 ml

                                                                  c) Tincture: 0.5 – 1 ml 3 times daily
                                                                      Daily dose: 1.5 - 3 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’).

                                                                  Duration of use

                                                                  If the symptoms persist longer than 1 week
                                                                  during the use of the medicinal product, a doctor

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 Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et
Arn., Grindelia camporum Greene, herba
EMA/HMPC/748220/2011                                                                                                   Page 3/6
                                                                  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 Asteraceae (Compositae)
                                                                 family.

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 or if dyspnoea, high fever or
                                                                  purulent sputum occurs, a doctor or a qualified
                                                                  health care practitioner should be consulted
                                                                  immediately.

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

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                              Traditional use

                                                                  None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                              Traditional use

                                                                  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

                                                                Hamamelis virginiana L., cortex;
                                                                Hamamelidis cortex (hamamelis bark)

                                                                i) Herbal substance

                                                                Not applicable



                                                                ii) Herbal preparations

                                                                    -   Dried comminuted herbal substance

                                                                    -   Tincture (Ratio of herbal substance to
                                                                        extraction solvent 1:10), extraction solvent
                                                                        ethanol 45% v/v

                                                                    -   Dry extract (DER 5-7.7:1), extraction
                                                                        solvent ethanol 30% m/m



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance for decoction for
                                                                oromucosal and anorectal use.

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

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

                                                                Herbal preparations in solid dosage forms for
                                                                rectal use.

                                                                Herbal preparations in liquid dosage forms for

2 The material complies with the Ph. Eur. monograph (2532).
3 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 Hamamelis virginiana L., cortex
EMA/HMPC/114583/2008                                                                                                 Page 3/8

                                     Classified as public by the European Medicines Agency
Well-established use                                            Traditional use

                                                                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

                                                                a) Traditional herbal medicinal product for relief
                                                                     of minor skin inflammation and dryness of the
                                                                     skin.

                                                                b) Traditional herbal medicinal product for
                                                                     symptomatic relief of itching and burning
                                                                     associated with haemorrhoids.

                                                                c)   Traditional herbal medicinal product used as a
                                                                     mouthwash and gargles for relief of minor
                                                                     inflammation of mucous membranes of the
                                                                     oral cavity.

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


4.2. Posology and method of administration

Well-established use                                            Traditional use

                                                                Posology

                                                                Indication a)

                                                                Adolescents, adults and elderly

                                                                Cutaneous use

                                                                Tincture in a strength corresponding to 5-10% in
                                                                semi-solid preparations, several times daily.

                                                                Dry extract (5-7.7:1; ethanol 30% m/m) in a
                                                                strength corresponding to 1.3% as an ointment,
                                                                several times daily.

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



                                                                Indication b)


Community herbal monograph on Hamamelis virginiana L., cortex
EMA/HMPC/114583/2008                                                                                           Page 4/8

                                    Classified as public by the European Medicines Agency
Well-established use                                            Traditional use

                                                                Adults and elderly

                                                                Anorectal use

                                                                Tincture in a strength corresponding to 5-10% in
                                                                semisolid and liquid preparations, several times
                                                                daily.

                                                                Comminuted herbal substance as a decoction:
                                                                5-10 g/250 ml, up to 3 times a day as
                                                                impregnated dressings.

                                                                Dry extract (5-7.7:1; ethanol 30% m/m) in a
                                                                strength corresponding to 1.3% as an ointment,
                                                                several times daily.

                                                                Rectal use

                                                                Suppositories containing 66 mg of dry extract
                                                                (5-7.7:1; ethanol 30% m/m), one suppository
                                                                two or three times daily.

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



                                                                Indication c)

                                                                Adolescents, adults and elderly

                                                                Tincture (1:10), ethanol 45% v/v (diluted 1:3,
                                                                with water): 2-4 ml, three times daily for gargles.

                                                                Comminuted herbal substance to be used as a
                                                                decoction, for gargles: 2-3 g up to 3 times daily.

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



                                                                Duration of use

                                                                Indications a) and c)

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



                                                                Indication b)

                                                                If the symptoms persist for more than 2 weeks

Community herbal monograph on Hamamelis virginiana L., cortex
EMA/HMPC/114583/2008                                                                                         Page 5/8

                                    Classified as public by the European Medicines Agency
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

                                                                Cutaneous use.

                                                                Oromucosal use.

                                                                Rectal use.

                                                                Anorectal 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

                                                                Indication a)

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

                                                                Indication b)

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

                                                                If rectal bleeding occurs a doctor should be
                                                                consulted.

                                                                Indication c)

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

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

                                                                For tinctures 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 Hamamelis virginiana L., cortex
EMA/HMPC/114583/2008                                                                                           Page 6/8

                                    Classified as public by the European Medicines Agency

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 contact dermatitis has 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 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

                                                                Hamamelis virginiana L., folium;Hamamelidis
                                                                folium (hamamelis leaf), dried or fresh leaf.

                                                                i) Herbal substance
                                                                   Not applicable

                                                                ii) Herbal preparations
                                                                    - Dried comminuted herbal substance
                                                                    - Tincture (fresh leaves) (Ratio of herbal
                                                                      substance to extraction solvent 1:10,
                                                                      extraction solvent ethanol 45% v/v)
                                                                    - Liquid extract (fresh leaves) (DER 1:1),
                                                                      extraction solvent ethanol 45% v/v
                                                                    - Liquid extract (DER 1:1), extraction
                                                                      solvent ethanol 30% m/m
                                                                    - Liquid extract (DER 1:2), extraction
                                                                      solvent ethanol 60% v/v



3.     PHARMACEUTICAL FORM

Well-established use                                            Traditional use

                                                                Comminuted herbal substance for decoction for
                                                                oromucosal or cutaneous use.
                                                                Herbal preparations in semisolid or liquid dosage
                                                                forms for cutaneous, anorectal or oromucosal use.
                                                                Herbal preparations in solid dosage forms for
                                                                rectal use.

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


1
 The dried material complies with the Ph. Eur. monograph (ref. 04/2008:0909)
2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

                                                         EMEA 2010                                                           2/7
4.     CLINICAL PARTICULARS

4.1.   Therapeutic indications

Well-established use                           Traditional use

                                                a) Traditional herbal medicinal product for relief
                                                   of minor skin inflammation and dryness of the
                                                   skin.
                                                b) Traditional herbal medicinal product for
                                                   symptomatic relief of itching and burning
                                                   associated with haemorrhoids.
                                                c) Traditional herbal medicinal product used as a
                                                   mouthwash and gargles for relief of minor
                                                   inflammation of mucous membranes of the
                                                   oral cavity.

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

4.2.   Posology and method of administration

Well-established use                           Traditional use

                                               Posology

                                               Indication a)

                                               Children over 6 years of age, adolescents, adults
                                               and elderly

                                               Tincture or liquid extracts (1:1, ethanol 45% v/v
                                               or ethanol 30% m/m) in a strength corresponding
                                               to 5-10% in semisolid and liquid preparations,
                                               several times daily.
                                               Liquid extract (1:2, ethanol 60% v/v) in a strength
                                               corresponding to 20% as a semi-solid preparation.

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


                                               Indication b)

                                               Adults and elderly
                                               Tincture or liquid extracts (1:1, ethanol 45% v/v
                                               or ethanol 30% m/m) in a strength corresponding
                                               to 5-10% in semisolid and liquid preparations,
                                               several times daily.
                                               Liquid extract (1:2, ethanol 60% v/v) in a strength
                                               corresponding to 20% as a semi-solid preparation,
                                               several times daily.


                                          EMEA 2010                                           3/7
                                 Comminuted herbal substance as a decoction:
                                 5-10 g/250 ml, up to 3 times a day as impregnated
                                 dressing.

                                 Rectal use
                                 Suppositories containing 400 mg of liquid extract
                                 (1:2, ethanol 60% v/v), one suppository 2-3 times
                                 a 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’).


                                 Indication c)

                                 Adolescents, adults and elderly
                                 Tincture (diluted 1:3 with water) 2-4 ml,
                                 three times daily for gargles.
                                 Comminuted herbal substance to be used as a
                                 decoction, for gargles: 2-3 g up to 3 times a day.

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

                                 Duration of use

                                 Indication a) and c)
                                 If the symptoms persist for more than 1 week
                                 during the use of the medicinal product, a doctor
                                 or a qualified health care practitioner should be
                                 consulted.

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


                                 Method of administration

                                 Cutaneous use.
                                 Rectal use.
                                 Anorectal use.
                                 Oromucosal use.

Contraindications

4.3.   Contraindications

Well-established use             Traditional use

                                 Hypersensitivity to the herbal substance.



                            EMEA 2010                                          4/7

Special warnings and precautions for use

4.4.   Special warnings and precautions for use

Well-established use                                  Traditional use

                                                      Indication a)
                                                      The use in children under 6 years of age has not
                                                      been established due to lack of adequate data.

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

                                                      If rectal bleeding occurs a doctor should be
                                                      consulted.

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

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

                                                      For extracts and 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

                                          Allergic contact dermatitis has 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

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

                                                       Hamamelis virginiana L.; Hamamelidis folium et
                                                       cortex aut ramunculus (hamamelis leaf and bark
                                                       or twigs)

                                                       i) Herbal substance
                                                          Not applicable

                                                       ii) Herbal preparations
                                                          1. Distillate prepared from fresh leaves and
                                                             bark (1:1.12-2.08; ethanol 6% m/m)

                                                          2. Distillate prepared from        dried    twigs
                                                             (1:2; ethanol 14-15%) 2



3.    PHARMACEUTICAL FORM


Well-established use                                   Traditional use

                                                       Herbal preparations in semisolid dosage forms for
                                                       cutaneous use and liquid dosage forms for ocular
                                                       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
  According to USP (USP-31- NF 26, 2008 Vol 3:3526) Distillate prepared from dried twigs (1:2; ethanol 14-
15%).

                                             EMEA 2010                                                  2/6
4.       CLINICAL PARTICULARS

4.1.     Therapeutic indications

Well-established use                                     Traditional use

                                                          a) Traditional herbal medicinal product for
                                                             relief of minor skin inflammation and
                                                             dryness of the skin.

                                                         b) Traditional herbal medicinal product to be
                                                            used for the temporary relief of eye
                                                            discomfort due to dryness of the eye or to
                                                            exposure to wind or sun.

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

4.2.     Posology and method of administration

Well-established use                                     Traditional use

                                                         Posology

                                                         Indication a)
                                                         Children over 6 years of age, adolescents, adults
                                                         and elderly

                                                         Distillate in a strength corresponding to 5-30% in
                                                         semi-solid preparations, several times a day.
                                                         The use is not recommended in children under
                                                         6 years of age (see section 4.4 ‘Special warnings
                                                         and precautions for use’).


                                                         Indication b)
                                                         Adolescents, adults and elderly
                                                         Eye drops 3 : Distillate (2) diluted       (1:10),
                                                         2 drops/each eye, 3-6 times daily.

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




3
    The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163)

                                               EMEA 2010                                               3/6
                                                  Duration of use

                                                  Indication a)

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


                                                  Indication b)

                                                  The recommended duration of use is 4 days. If the
                                                  symptoms persist for more than 2 days during the
                                                  use of the medicinal product, a doctor or a
                                                  qualified health care practitioner should be
                                                  consulted.


                                                  Method of administration

                                                  Cutaneous use.
                                                  Ocular 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 a)
                                                  The use in children under 6 years of age has not
                                                  been established due to lack of adequate data.

                                                  Indication b)
                                                  Stop use and ask a doctor if you experience eye
                                                  pain, changes in vision, continued redness, or
                                                  irritation of the eye, or if the condition worsens or
                                                  persists for more than 48 hours.

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

                                                  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.




                                        EMEA 2010                                                  4/6

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

                                                  Indication a)
                                                  Allergic contact dermatitis may occur in sensitive
                                                  patients. The frequency is not known.

                                                  Indication b)
                                                  Conjunctivitis cases 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

                                                                Harpagophytum procumbens DC. and/or
                                                                Harpagophytum zeyheri Decne., radix; Devil’s
                                                                claw root

                                                                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 30% V/V
                                                                 d) Soft extract (DER 2.5-4.0:1), extraction
                                                                        solvent ethanol 70% V/V
                                                                 e) Dry extract (DER 1.5-2.5:1), extraction
                                                                        solvent water
                                                                 f)     Dry extract (DER 5-10:1), extraction solvent
                                                                        water
                                                                 g) Dry extract (DER 2.6-4:1), extraction
                                                                        solvent ethanol 30% V/V
                                                                 h) Dry extract (DER 1.5-2.1:1), extraction
                                                                        solvent ethanol 40% V/V
                                                                 i)     Dry extract (DER 3-5:1), extraction solvent
                                                                        ethanol 60% V/V
                                                                 j)     Dry extract (DER 3-6:1), extraction solvent
                                                                        ethanol 80% V/V



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.: 1095)



European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
EMA/HMPC/627057/2015                                                                                                Page 3/8
 Well-established use                                        Traditional use

                                                              k) Dry extract (DER 6-12:1), extraction solvent
                                                                   ethanol 90% V/V
                                                              l)   Tincture (ratio of herbal substance to
                                                                   extraction solvent 1:5), extraction solvent
                                                                   ethanol 25% (V/V)


3. Pharmaceutical form
 Well-established use                                        Traditional use

                                                             Comminuted herbal substance as herbal tea for
                                                             oral use.

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

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



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                        Traditional use

                                                             Indication 1)

                                                             Traditional herbal medicinal product for relief of
                                                             minor articular pain.

                                                             Indication 2)

                                                             Traditional herbal medicinal product used for the
                                                             relief of mild digestive disorders such as bloating
                                                             and flatulence and where there is temporary loss
                                                             of appetite.

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




European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
EMA/HMPC/627057/2015                                                                                         Page 4/8
                                                                      3
4.2. Posology and method of administration

 Well-established use                                         Traditional use

                                                              Posology

                                                              Adults and elderly

                                                              Indication 1)

                                                              a) Herbal tea: 4.5 g in 500 ml of boiling water as
                                                                 herbal infusion divided in 3 single doses
                                                                 Infusion time: 8 hours
                                                              b) Single dose: 435 mg, 3 times daily
                                                                 Daily dose: 1.35 g
                                                              c) Daily dose: 1.03 g extract as single dose
                                                              d) Daily dose: 240 mg extract as single dose
                                                              e) Single dose: 100-1200 mg, 2 to 3 times daily
                                                                 Daily dose: up to 2.4 g
                                                              f) Single dose: 200-400 mg, 2 to 3 times daily
                                                                 Daily dose: 600-800 mg
                                                              g) Single dose: 400-800 mg, 2 to 4 times daily
                                                                 Daily dose: 800 mg up to 1.6 g
                                                              h) Single dose: 300-900 mg, 2 to 3 times daily
                                                                 Daily dose: 600 mg up to 2.7 g
                                                              i) Single dose: 480 mg, 2 times daily
                                                                 Daily dose: 960 mg
                                                              k) Single dose: 45 mg, 2 times daily
                                                                 Daily dose: 90 mg
                                                              l) Single dose: 0.5-1 ml, 3 times daily
                                                                 Daily dose: up to 3 ml

                                                              Indication 2)

                                                              a) Herbal tea: 1.5 g in 250 ml boiling water as
                                                                 herbal infusion divided in 3 single doses.
                                                                 Infusion time: 8 hours
                                                              d) Daily dose: 240 mg extract as single dose
                                                              e) Single dose: 100 mg, 2 to 3 times daily
                                                                 Daily dose: up to 300 mg
                                                              g) Single dose: 140-280 mg, 3 times daily
                                                                 Daily dose: 420 up to 840 mg
                                                              i) Single dose: 480 mg, 2 times daily
                                                              j) Single dose: 100 mg, 3 times daily
                                                                 Daily dose: 300 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’).



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 Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
EMA/HMPC/627057/2015                                                                                             Page 5/8
 Well-established use                                        Traditional use

                                                             Duration of use

                                                             Indication 1)

                                                             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.

                                                             Indication 2)

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

                                                             Method of administration

                                                             Oral use

Contraindications

4.3. Contraindications

 Well-established use                                       Traditional use

                                                            Hypersensitivity to the active substance.

                                                            Patients with active gastric or duodenal ulcer.

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.

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

                                                             Patients with gallstones should consult a
                                                             physician prior to use devil's claw.

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

                                                             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.




European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
EMA/HMPC/627057/2015                                                                                         Page 6/8

Interactions with other medicinal products and other forms of interaction

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

 Well-established use                                        Traditional use

                                                             None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                        Traditional use

                                                             Gastrointestinal symptoms (diarrhoea, nausea,
                                                             vomiting, abdominal pain) have been reported.

                                                             Central nervous system effects (headache,
                                                             vertigo) have been reported.

                                                             Hypersensitivity reactions (e.g. rash, hives, facial
                                                             oedema) 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 marketing authorisation
 application of Article 10(a) of
 Directive 2001/83/EC

 Hedera helix L., folium (ivy leaf)

 i) Herbal substance

 Not applicable

 ii) Herbal preparations

 a) Dry extract (DER 4-8:1), extraction solvent
      ethanol 24-30% m/m

 b) Dry extract (DER 6-7:1), extraction solvent
      ethanol 40% m/m

 c)   Dry extract (DER 3-6:1), extraction solvent
      ethanol 60% m/m

 d) Liquid extract (DER 1:1), extraction solvent
      ethanol 70% V/V

 e) Soft extract (DER 2.2-2.9:1), extraction solvent
      ethanol 50% V/V: propylene glycol (98:2)


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.




1 The material complies with the Ph. Eur. monograph (ref.: 2148).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

European Union herbal monograph on Hedera helix L., folium
EMA/HMPC/325716/2017                                                                                                 Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                        Traditional use

 Herbal medicinal product used as an expectorant in
 case of productive cough.


4.2. Posology and method of administration

 Well-established use                                        Traditional use

 Posology

 Adolescents, adults and elderly

 a) Single dose: 15-65 mg, one to three times daily
      Daily dose: 45-105 mg
      (Note: maximum daily dose for ethanol-
      containing finished products :67 mg;
      corresponding to 420 mg herbal substance)

 b) Single dose: 14-18 mg three times daily
      Daily dose: 42-54 mg

 c)   Single dose: 33 mg two times daily
      Daily dose: 66 mg

 d) Single dose: 100 mg three times daily
      Daily dose: 300 mg

 e) Single dose: 40 mg three times daily
      Daily dose: 120 mg

 Children between 6-11 years of age

 a) Single dose: 11-35 mg, two to three times daily
      Daily dose: 33-70 mg.
      (Note: maximum daily dose for ethanol-
      containing finished products: 34 mg;
      corresponding to 210 mg herbal substance)

 b) Single dose: 9-18 mg, one to three times daily
      Daily dose: 15-40 mg

 c)   Single dose: 25 mg, two times daily
      Daily dose: 50mg

 d) Single dose: 75 mg, three times daily
      Daily dose: 225 mg

 e) Single dose: 20-26 mg, three to four times Daily
      Daily dose: maximum of 80 mg




European Union herbal monograph on Hedera helix L., folium
EMA/HMPC/325716/2017                                                           Page 4/7
 Well-established use                                         Traditional use


 Children between 2-5 years of age

 a) Single dose: 8-18 mg, two to three times daily
      Daily dose: 24-36 mg
      (Note: maximum daily dose for ethanol-
      containing finished products: 24 mg;
      corresponding to 150 mg herbal substance)

 b) Single dose: 7-9 mg, two to three times daily
      Daily dose: 14-27 mg

 c)   Single dose: 17 mg, two times daily
      Daily dose 34 mg

 e) Single dose: 20 mg, three times daily
      Daily dose: 60 mg

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

 Duration of use

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

 Method of administration

 Oral use

Contraindications

4.3. Contraindications

 Well-established use                                        Traditional use

 Hypersensitivity to the active substance or to plants
 of the Araliaceae family.

 Children under 2 years of age because of the
 general risk of aggravation of respiratory symptoms
 through secretolytic drugs.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                        Traditional use

 Persistent or recurrent cough in children between 2-
 4 years of age requires medical diagnosis before
 treatment.

 When dyspnoea, fever or purulent sputum occurs, a
 doctor or a pharmacist should be consulted.

 Caution is recommended in patients with gastritis



European Union herbal monograph on Hedera helix L., folium
EMA/HMPC/325716/2017                                                            Page 5/7
 Well-established use                                        Traditional use

 or gastric ulcer.

 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.

 Preparation d) should not be administered to
 children under 6 years of age because of the
 alcohol content.

Interactions with other medicinal products and other forms of interaction

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

 Well-established use                                        Traditional use

 None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                        Traditional use

 Gastrointestinal reactions (nausea, vomiting,
 diarrhoea) have been reported. The frequency is
 not known.

 Allergic reactions (urticaria, skin rash, dyspnoea,
 anaphylactic reaction) have been reported. The
 frequency is not known.

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


European Union herbal monograph on Hedera helix L., folium
EMA/HMPC/325716/2017                                                           Page 6/7
 Well-established use                                        Traditional use

 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

                                                               Helichrysum arenarium (L.) Moench, flos (sandy
                                                               everlasting)

                                                               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 in
                                                                digestive disorders with a feeling of fullness and
                                                                bloating.
                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication
                                                                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.
3
 The herbal substance complies with the monograph Helichrysi flos in Farmakopea Polska X, 2014, Vol. II, p. 4039


European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos
EMA/HMPC/41108/2015                                                                                                 Page 2/5
4.2. Posology and method of administration 4

Well-established use                                           Traditional use

                                                               Posology

                                                               Adults and elderly
                                                               Single dose

                                                               1.5 g of comminuted herbal substance in 150-
                                                               250 ml of water as a decoction for 10 minutes 2 -
                                                               3 times daily.

                                                               or

                                                               3 g of comminuted herbal substance, in 150-
                                                               200 ml of boiling water, as an infusion, 1 - 3
                                                               times daily.

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

                                                               Duration of use

                                                               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

                                                               To be taken 15-30 minutes before meal or when
                                                               the symptoms appear.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

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

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.

                                                               Due to the possible stimulation of bile secretion


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 Helichrysum arenarium (L.) Moench, flos
EMA/HMPC/41108/2015                                                                                              Page 3/5
Well-established use                                           Traditional use

                                                               Helichrysi flos is not recommended in case of
                                                               obstruction of the bile duct, cholangitis, liver
                                                               disease and gallstones.

                                                               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.