Draft Community Herbal Monograph On Phaseolus Vulgaris L., Fructus Sine Semine
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 March 2013
EMA/HMPC/317319/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Phaseolus vulgaris L., fructus sine semine
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Phaseolus vulgaris L., fructus sine semine; Phaseoli fructus sine semine; green bean pod
BG (balgarski): $acyn, nnog 6e3 ceMeHa CS (cestina): fazolovy plod bez semen DA (dansk):
DE (Deutsch): (Samenfreie) Gartenbohnenhülsen EL (elliniká): OaaióAou Kapnôç aveu aneppárav EN (English): green bean (pod)
ES (espanol): Judía
ET (eesti keel): aedoa seemneteta kaun FI (suomi): tarhapapu (ilman siementä)
FR (français): haricot (fruit sans graine d')
HU (magyar): babhüvely IT (italiano):
LT (lietuviq kalba): Pupeliq ankstys (be seklq)
LV (latviesu valoda): Pupigas augji (bez sekläm) MT (malti): Frott tal-Fazola NL (nederlands): gewone boon (peul zonder zaden)
PL (polski): owocnia fasoli PT (portugués): feijao RO (romana):
SK (slovencina): Plod fazule (bez semien)
SL (slovenscina): plod fizola (brez semena)
SV (svenska): bönskida (utan frö)
IS (íslenska):
NO (norsk): hagebonnebelg (uten frö)_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
May 2012 September 2012 November 2012 January 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 March 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 July 2013 |
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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, 2013. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Phaseolus vulgaris L., fructus sine semine
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 Phaseolus vulgaris L., fructus sine semine (green bean pod) i) Herbal substance Not applicable. ii) Herbal preparations Comminuted herbal substance |
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. 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 used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance
2 The material complies with DAC 1986
4.2. Posology and method of administration3
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Well-established use |
Traditional use |
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Posology Adults and elderly Single dose Herbal tea: 2.5 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 2 - 6 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 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. |
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 lack of data. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. |
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. |
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).
4.6. Fertility, 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. No fertility data available. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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Not relevant. |
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
12 March 2013
Page 5/5
Community herbal monograph on Phaseolus vulgaris L., fructus sine semine
EMA/HMPC/317319/2012