Draft Community Herbal Monograph On Rubus Idaeus L., Folium
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 March 2013 EMA/HMPC/44211/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Rubus idaeus L., folium
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Rubus idaeus L., folium; Rubi idaei folium; raspberry leaf
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Discussion in Working Party on Community monographs and Community list (MLWP) |
January 2012 March 2012 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 September 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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BG (balgarski): Ma^MHa, ^mct |
LT (lietuviq kalba): Paprastj avieciq. lapai |
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CS (cestina): maliníkovy list |
LV (latviesu valoda): Avenes lapas |
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DA (dansk): Hindbærblad |
MT (malti): Werqa tal-ghollieq |
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DE (Deutsch): Himbeerblätter |
NL (nederlands): Frambozenblad |
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EL (elliniká): Bótou lôaiaç 9ÙÀÀ0 |
PL (polski): Lisc maliny |
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EN (English): Raspberry Leaf |
PT (portugues): Framboeseiro, folha |
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ES (español): Frambueso, hoja de |
RO (romånä): |
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ET (eesti keel): vaarikaleht |
SK (slovencina): List maliny |
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FI (suomi): vadelma, lehti |
SL (slovenscina): list malinjaka |
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FR (français): Ronce (feuille de) |
SV (svenska): Hallonblad |
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HU (magyar): málnalevél |
IS (islenska): |
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IT (italiano): |
NO (norsk): Bringeb^rblad |
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Rubus idaeus L., folium
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 Rubus idaeus L., folium (raspberry leaf) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Dry extract (DER 4:1): extraction solvent water |
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 and for infusion preparation for oromucosal use. Herbal preparations in solid dosage form 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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Indication 1) Traditional herbal medicinal product for the symptomatic relief of minor spasm associated with |
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. Fr. monograph 'Ronce - Rubus' (Ph. Fr. XI edition).
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Well-established use |
Traditional use |
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menstrual periods. Indication 2) Traditional herbal medicinal product for the symptomatic treatment of mild inflammation in the mouth or throat. Indication 3) Traditional herbal medicinal product for the symptomatic treatment of mild diarrhoea. 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
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Well-established use |
Traditional use |
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Posology Indication 1) Adults Single dose Dry extract: 113-226 mg up to 3 to 4 times daily. Indication 2) Adults and elderly Single dose Comminuted herbal substance for infusion preparation for oromucosal use: 1.5-8 g of the comminuted herbal substance in 150 ml of boiling water, 3 times daily. Indication 3) Adults and elderly Single dose Herbal tea: 1.5-8 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion, 3 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).
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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 (see section 4.4 'Special warnings and precautions for use'). Duration of use Indications 1) and 2) If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indication 3) If the symptoms persist longer than 3 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted Method of administration Indication 1) Oral use. To be taken after meals. Indication 2) Oromucosal use. Indication 3) Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s). |
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 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. |
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. 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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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
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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. Adequate tests on reproductive toxicity and tests on 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 7/6
Community herbal monograph on Rubus idaeus L., folium
E MA/H MPC/44211/2012