Draft Community Herbal Monograph On Cucurbita Pepo L., Semen
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
13 September 2011
EMA/HMPC/136024/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Cucurbita pepo L., semen
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Cucurbita pepo L., semen; Cucurbitae semen; pumpkin seed
BG (balgarski): 06nKHOBeHa TMKBa, ceMe CS (cestina): tykvové semeno DA (dansk): Græskarfr0 DE (Deutsch): Kürbissamen EL (ellinika):
EN (English): pumpkin seed ES (espanol): Calabaza, semillas de ET (eesti keel): körvitsaseeme FI (suomi):
FR (français): Courge citrouille (graine de) HU (magyar): Kozonséges tökmag IT (italiano): Zucca seme_
LT (lietuviq kalba):
LV (latviesu valoda): Kirbja seklas MT (malti):
NL (nederlands): Pompoenzaad PL (polski): nasienie dyni PT (portugués): Abóbora, semente RO (romana): seminte de dovleac SK (slovencina): Tekvicové semeno SL (slovenscina): seme navadne buce SV (svenska): Pumpafrö IS (íslenska):
NO (norsk): Gresskarfr0_
|
Discussion in Working Party on Community monographs and Community list (MLWP) |
September 2010 November 2010 January 2011 May 2011 |
|
Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
September 2011 |
|
End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 February 2012 |
|
Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
|
Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
An agency of the European Union
7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail info@ema.europa.eu Website www.ema.europa.eu
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Cucurbita pepo L., semen
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 Cucurbits pepo L., semen (pumpkin seed) i) Herbal substance Whole, ripe and dried seeds ii) Herbal preparations a) Comminuted herbal substance b) Soft extract (DER 15-25:1), extraction solvent ethanol 92% m/m c) Dry extract (15-30:1), extraction solvent ethanol 60% v/v d) Fatty oil |
3. Pharmaceutical form
|
Well-established use |
Traditional use |
|
Herbal substance or 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 for the relief of lower urinary tract symptoms related to benign |
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 German Monograph (DAB 10, 1991-1996).
|
Well-established use |
Traditional use |
|
prostatic hyperplasia or related to an overactive bladder, after serious conditions have been excluded by a medical doctor. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. |
4.2. Posology and method of administration
|
Well-established use |
Traditional use |
|
Posology Adults and elderly Daily dose Herbal substance 10-20 g to be taken in one single dose or divided into 2 - 3 doses. Herbal preparations a) Comminuted herbal substance 10-20 g divided into 2-3 doses. b) Soft extract 1000 mg divided into 2 single doses. c) Dry extract 300-320 mg, divided into 2-3 single doses. d) Fatty oil 1-4 g daily divided into several single doses. The use in children and adolescents under 18 years of the age is not recommended (see section 4.4. 'Special warnings and precautions for use'). Duration of use If the symptoms persist longer than 4 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oral use. |
4.3. Contraindications
|
Well-established use |
Traditional use |
|
Hypersensitivity to the active substance or to other plants of the Cucurbitaceae family. |
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 complaints or symptoms such as fever, spasms or blood in the urine occur during the use of medicinal product, a doctor or a qualified health care professional should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
|
Well-established use |
Traditional use |
|
None reported. |
4.6. Fertility, pregnancy and lactation
|
Well-established use |
Traditional use |
|
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
|
Well-established use |
Traditional use |
|
No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
|
Well-established use |
Traditional use |
|
None known. If adverse reactions occur, a doctor or a qualified |
|
Well-established use |
Traditional use |
|
health care practitioner should be consulted. |
4.9. Overdose
|
Well-established use |
Traditional use |
|
No case of overdose has been reported. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
|
Well-established use |
Traditional use |
|
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
|
Well-established use |
Traditional use |
|
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data
|
Well-established use |
Traditional use |
|
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
|
Well-established use |
Traditional use |
|
Not applicable. |
7. Date of compilation/last revision
13 September 2011
Community herbal monograph on Cucurbita pepo L., semen
EMA/HMPC/136024/2010
Page 6/5