Draft Community Herbal Monograph On Arnica Montana L., Flos
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
9 July 2013
EMA/HMPC/198793/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Arnica montana L., flos
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Arnica montana L., flos; Arnica Flower
BG (balgarski): ApHMKa, ^BflT
CS (cestina): kvët prhy chlumní
DA (dansk): Arnikablomst
DE (Deutsch): Arnikablüten
EL (elliniká): dv0oç apvaKiôoç 9apvknO- àv0oç
apvkgç
EN (English): Arnica Flower ES (español): Árnica, flor de ET (eesti keel): arnikaoisik FI (suomi): etelanarnikki, kukka FR (français): Arnica (fleur d')
HU (magyar): Hegyi árnika virág HR (hrvatska):
IT (italiano): Arnica fiore_
LT (lietuviq kalba): Arnikq ziedai LV (latviesu valoda): Arnikas ziedi MT (malti): Fjura ta' l-Arnika NL (nederlands): Valkruid, Wolverlei PL (polski): Kwiat arniki PT (portugués): Arnica, flor RO (romana): floare de arnica SK (slovencina): Kvet arniky horskej SL (slovenscina): cvet navadne arnike SV (svenska): Arnikablomma IS (íslenska):
NO (norsk): Arnikablomst
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Discussion in Working Party on Community monographs and Community list (MLWP) |
March 2012 May 2012 November 2012 March 2013 May 203 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
9 July 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 December 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 Arnica montana L., 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 Arnica montana L.,flos i) Herbal substance Not applicable. ii) Herbal preparations a) Tincture (1:10), extraction solvent: ethanol 70% (V/V) b) Tincture (1:5), extraction solvent: ethanol 60% (V/V) c) Liquid extract of fresh flowers (1:20), extraction solvent: ethanol 50% (m/m) |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparations in semi-solid dosage forms for cutaneous 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 relief of bruises, sprains and localised muscular pain. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2 When dried, the material complies with the Ph. Eur. monograph (ref.: 04/2008, 1391)
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Well-established use |
Traditional use |
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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
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Well-established use |
Traditional use |
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Adolescents, adults and elderly a) semi-solid dosage form (21.5% tincture in ointment base) Apply a thin layer on the affected area, two to three times daily. b) semi-solid dosage form (20% tincture in base) Apply a thin layer on the affected area, two to three times daily. c) semi-solid dosage form (50% liquid extract in base) Apply a thin layer on the affected area, two to four times daily. The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions of use'). Duration of use If the symptoms persist after 3 to 4 days during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted. Method of administration Cutaneous use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance and to other plants of the Asteraceae (Compositae) family. |
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 under 12 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. The semi-solid dosage form should not be used on broken skin. |
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 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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Allergic reactions such as itching, redness of the skin and eczema may occur. The frequency is not 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, 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
9 July 2013
Page 5/5
Community herbal monograph on Arnica montana L., flos
EMA/HMPC/198793/2012