Draft Community Herbal Monograph On Commiphora Molmol Engler, Gummi-Resina
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 September 2010 EMA/HMPC/96911/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Commiphora molmol Engler, gummi-resina
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Commiphora molmol Engler, gummi-resina; myrrha; myrrh
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Discussion in Working Party on Community monographs and Community list (MLWP) |
July 2010 September 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
September 2010 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 March 2011 |
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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): |
LT (lietuviq kalba): |
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CS (cestina): |
LV (latviesu valoda): |
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DA (dansk): |
MT (malti): |
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DE (Deutsch): myrrhe |
NL (nederlands): |
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EL (ellinika): |
PL (polski): |
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EN (English): myrrh |
PT (portugués): |
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ES (espanol): |
RO (româna): |
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ET (eesti keel): |
SK (slovencina): |
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FI (suomi): |
SL (slovenscina): |
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FR (français): myrrhe (gomme oleo-résine) |
SV (svenska): |
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HU (magyar): |
IS (íslenska): |
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IT (italiano): |
NO (norsk): |
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© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Commiphora molmol Engler, gummi-resina
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 Commiphora molmol Engler, gummi-resina (myrrh) i) Herbal substance Not applicable ii) Herbal preparations Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 90 % V/V) |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparation in liquid dosage forms for oromucosal or 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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Indication 1) Traditional herbal medicinal product for treatment |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1349 corrected 6.0).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
of minor ulcers and inflammation in the mouth (stomatitis and gingivitis).
Indication 2)
Traditional herbal medicinal product for treatment of minor wounds and small boils (furuncles).
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 administration
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Well-established use |
Traditional use |
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Posology Oromucosal use Indication 1) Adolescents, adults and elderly i) 0.5-5 ml of tincture in 150 ml of water for rinsing or gargling 3 times daily. or ii) The undiluted tincture is applied to the affected areas with a cotton bud 2-3 times daily. The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Cutaneous use Indication 2) Adolescents, adults and elderly The wound or furuncle is dabbed 2-3 times daily with undiluted (preferably) or diluted tincture in water. The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use If the symptoms persist after 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oromucosal and 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 is not recommended 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 appropriate labelling for ethanol, taken from the 'Guideline on excipients in the label and package leaflet of medicinal products for human use', must be included. Indication 2) If fever or signs of exacerbating skin infection are observed, a doctor or a qualified health care practitioner should be consulted. Small boils (furuncles) in the face should be treated by a medical doctor. Eye contact with myrrh tincture should be avoided. |
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. 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. |
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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Allergic skin reactions have been reported. The frequency is not known. The tincture contains alcohol, which may cause a transient pain and irritation on application to the mucosa or skin. If other adverse reactions not mentioned above 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 genotoxicity have not been performed.
Tests on reproductive toxicity and carcinogenic potential 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 September 2010
Page 6/6
Community herbal monograph on Commiphora molmol Engler, gummi-resina
EMA/HMPC/96911/2010