Draft Community Herbal Monograph On Rosa Centifolia L.; Rosa Gallica L.; Rosa Damascena Mill., Flos
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 December 2013
EMA/HMPC/137299/2013
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos; Rosae flos; Rose flower
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Discussion in Working Party on Community monographs and Community |
May 2013 |
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list (MLWP) |
July 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
17 September 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 April 2014 |
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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
An agency of the European Union
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
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BG (bulgarski): MacmgaüHa po3a, ^at |
LT (lietuviq kalba): Roziq ziedai |
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CS (cestina): ruzovy kvët |
LV (latviesu valoda): Rozu ziedi |
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DA (dansk): Rosenblomst |
MT (Malti): Fjura tal-Ward |
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DE (Deutsch): Rosenblütenblätter |
NL (Nederlands): Roos, bloem |
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EL (elliniká): Pôôou dv0oç |
PL (polski): Kwiat rózy |
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EN (English): Rose flower |
PT (portugués): Rosa, flor |
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ES (español): Rosa, flor de |
RO (romana): |
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ET (eesti keel): kibuvitsaôis |
SK (slovencina): Kvet ruze |
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FI (suomi): ruusu, kukka |
SL (slovenscina): cvet vrtnice |
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FR (français): Rose pâle, rose de Provins, rose de |
SV (svenska): Rosenblad |
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Damas |
IS (íslenska): |
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HR (hrvatski): ruzin cvijet |
NO (norsk): Roseblomst |
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HU (magyar): Rózsavirág | |
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IT (italiano): Rosa fiore |
Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos
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 Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos (Rose flower) i) Herbal substance Dried petals ii) Herbal preparations Comminuted herbal substance |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal substance or comminuted herbal substance for infusion preparation for oromucosal or cutaneous use. The pharmaceutical form should be described by 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 used for mild inflammations of the oral and pharyngeal mucosa. |
1 The material complies with the monograph in the Ph. Fr. XI edition (Rose pale 1989; Rose rouge 1989).
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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Indication 2) Traditional herbal medicinal product used for relief of minor skin inflammation. 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) Adolescents over 12 years of age, adults and elderly Single dose Herbal substance or comminuted herbal substance for infusion preparation for oromucosal use: 1 - 2 g of the herbal substance or comminuted herbal substance in 200 ml of boiling water As a mouth rinse, 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'). Indication 2) Adolescents over 12 years of age, adults and elderly Single dose Herbal substance or comminuted herbal substance for infusion preparation for cutaneous use: 1 - 2 g of the herbal substance or comminuted herbal substance in 200 ml of boiling water Apply on the affected area, up to 3 times daily, in the form of a wet, impregnated dressing. The use in children under 12 years of age is not |
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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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. Method of administration Oromucosal use. Cutaneous 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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Indications 1) and 2) The use in children under 12 years of age has not been established due to lack of adequate. |
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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No fertility data available. 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 reported. 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. Tests on genotoxicity, reproductive toxicity 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
15 December 2013
EMA/HMPC/137299/2013 Page 7/7