Draft Community Herbal Monograph On Echinaceae Angustifolia Dc., Radix
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
31 March 2011
EMA/HMPC/688216/2008
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Echinacea angustifolia DC., radix
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Echinacea angustifolia DC., radix; Echinaceae angustifoliae radix; narrowleaved coneflower root
Draft
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Discussion in Working Party on Community monographs and Community list (MLWP) |
January 2009 May 2009 November 2009 January 2011 March 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 November 2009 |
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Release of draft public statement for public consultation postponed |
2010 |
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Adoption of draft monograph by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
31 March 2011 |
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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 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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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
BG (bälgarski): fltnronncTHa exMHacea, KopeH CS (cestina): koren trapatky úzkolisté DA (dansk): Smalbladet solhatrod DE (Deutsch): Schmalblättriger-Sonnenhut-Wurzel
EL (elliniká): ExivaKeaa arevo^uÀÀou piÇa EN (English): narrow-leaved coneflower root ES (espanol): Equinácea oficinal, raíz de ET (eesti keel): ahtalehise siilkübara juur FI (suomi):
FR (français): Echinacea angustifolia (racine d') HU (magyar): Keskenylevelu kasvirág gyôkér IT (italiano): Echinacea angustifoglia radice
LT (lietuviq. kalba):
LV (latviesu valoda): Saurlapu ehinacejas saknes MT (malti): Gherq ta' l-Echinacea NL (nederlands): Rode Zonnehoed PL (polski): Korzen jezówki wqskolistnej PT (portugués): Equinácia angustifólia, raiz RO (romana):
SK (slovencina): Koren echinacey úzkolistej SL (slovenscina): korenina ozkolistne ehinaceje SV (svenska): Liten läkerudbeckiarot IS (íslenska):
NO (norsk): Smalbladet solhatt, rot
Community herbal monograph on Echinacea angustifolia DC., radix
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 | |
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Echinacea angustifolia DC., radix (narrow-leaved coneflower root) | |
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i) Herbal substance | |
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Not applicable | |
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ii) Herbal preparations | |
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a) Comminuted herbal substance | |
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b) Powdered herbal substance |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1821 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
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. Herbal preparations in solid dosage forms 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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Traditional herbal medicinal product for supportive treatment of common cold. 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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Posology Adolescents, adults and elderly Single dose a) Herbal tea: 1 g of the comminuted herbal substance in 150 ml of water as a decoction 3 times daily. b) 250-500 mg, 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'). Duration of use The therapy should start at first signs of common cold. If the symptoms persist longer than 10 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be |
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Well-established use |
Traditional use |
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consulted. Method of administration Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s) 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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Not recommended in cases of progressive systemic diseases such as tuberculosis, diseases of the white blood cells system, collagenoses, multiple sclerosis, AIDS, HIV infections and other immune diseases. If the symptoms worsen or high fever occurs during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. There is a possible risk of allergic reactions in sensitive individuals. Those patients should consult their doctor before using Echinacea. There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea. The use in children under 12 years of age has not been established due to lack of adequate data. |
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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Hypersensitive reactions (skin reactions) may occur. 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
31 March 2011
Page 8/6
Community herbal monograph on Echinacea angustifolia DC., radix
EMA/HMPC/688216/2008