Draft Community Herbal Monograph On Capsella Bursa-Pastoris (L.) Medikus, Herba
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
25 November 2010
EMA/HMPC/262766/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Capsella bursa-pastoris (L.) Medikus, herba; Bursae pastoris herba; shepherd's purse.
BG (balgarski):
CS (cestina):
DA (dansk):
DE (Deutsch): Hirtentaschelkraut EL (ellinika):
EN (English): shepherd's purse ES (espanol): bolsa de pastor ET (eesti keel):
FI (suomi):
FR (français): bourse à pasteur HU (magyar):
IT (italiano):_
LT (lietuviq. kalba):
LV (latviesu valoda):
MT (malti):
NL (nederlands): herderstasje PL (polski):
PT (português):
RO (româna):
SK (slovencina):
SL (slovenscina):
SV (svenska):
IS (íslenska):
NO (norsk):_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
May 2010 September 2020 November 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
25 November 2010 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 April 2011 |
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Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba.
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1,2
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Well-established use |
Traditional use |
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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Capsella bursa-pastoris (L.) Med. (syn.: Thlaspi bursa-pastoris L.), herba (shepherd's purse) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. Herbal preparations in liquid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
4. Clinical particulars
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Traditional herbal medicinal product for the reduction of heavy menstrual bleeding in women with regular menstrual cycles, after serious |
1 The material complies with (ref.: Ph. Fr. (10e edition) as amended by additive no 38, 1997).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
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Well-established use |
Traditional use |
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conditions have been excluded by a medical doctor. 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
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Well-established use |
Traditional use |
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Posology Adults and elderly Use to be started 3-5 days before the menstruation and to be applied during the whole menstrual cycle. a) Comminuted herbal substance: 1-5 g as a single dose for the preparation of herbal tea, 2-4 times daily (daily dosage: 3-20 g). b) Liquid extract: 1-4 ml as a single dose, 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 during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The use in children and adolescents under 18 years of age is not recommended because of concerns requiring medical advice. If the symptoms worsen during the use of the |
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Well-established use |
Traditional use |
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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 package leaflet of medicinal products for human use', must be included. |
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use |
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None reported. |
4.6. Pregnancy and lactation
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Well-established use |
Traditional use |
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Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
|
Well-established use |
Traditional use |
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No case of overdose has been reported. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
25 November 2010
Community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba
EMA/HMPC/262766/2010
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