Draft Community Herbal Monograph On Viola Tricolor L.
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
6 May 2010
EMA/HMPC/131734/2009
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; ; Viola tricolor L.; Viola arvensis Murray (Gaud); Viola vulgaris Koch (Oborny); Violae herba cum flore; wild pansy, heartsease
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Discussion in Working Party on Community monographs and Community list (MLWP) |
March 2009 September 2009 November 2009 January 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
11 March 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 August 2010 |
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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 (bälgarski): |
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): |
NL (nederlands): |
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EL (ellinika): |
PL (polski): |
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EN (English): |
PT (português): |
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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): |
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 Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
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 Viola tricolor L. and/or species Viola arvensis Murray (Gaud.) and Viola vulgaris Koch (Oborny), herba cum flore (wild pansy, heartsease) i) Herbal substance Not applicable. ii) Herbal preparations Comminuted herbal substance |
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 or for infusion preparation for cutaneous use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008: 1855).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
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 symptomatic treatment of mild seborrhoeic skin condition. 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 Adolescents and adults a) Oral use Herbal tea: 3 g of comminuted herbal substance in 250 ml of boiling water as an infusion 1-3 times daily. b) Cutaneous use - 5-20 g/L of comminuted herbal substance as an infusion. Apply as a wet dressing to the affected areas of the skin 2-3 times daily. - Bath additive: 5-10 g/L of comminuted herbal substance as an infusion. 1 litre of infusion to be added to the bath. The use in children under 12 years of the age is not recommended (see section 4.4. 'Special warnings and precautions for use'). Duration of use Oral use Not be used for more than 2 weeks. Cutaneous use Cutaneous dressings 2-3 times daily for 1 week. Full baths should only be taken after a doctor or a qualified health care practitioner has been consulted. Method of administration |
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Well-established use |
Traditional use |
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Oral use. Cutaneous use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance, or to salicylates. Cutaneous use Open wounds, large areas of damaged skin. |
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. Hot baths should not be used in case of febrile or infectious illnesses, in heart insufficiency and hypertension. |
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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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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One case of haemolysis in a child with G6PD deficiency has been reported. The frequency is not known. 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. 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
6 May 2010
Page 6/6
Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
EMA/HMPC/131734/2009