Draft Community Herbal Monograph On Taraxacum Officinale Weber Ex Wigg., Folium
European Medicines Agency Evaluation of Medicines for Human Use
London, 14 January 2009 Doc. Ref.: EMEA/HMPC/579636/2008
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DISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP) |
November 2008 January 2009 |
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ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION |
14 January 2009 |
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END OF CONSULTATION (DEADLINE FOR COMMENTS) |
15 May 2009 |
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REDISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP) | |
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ADOPTION BY HMPC |
Comments should be provided using this template to hmpc.secretariat@ emea.europa.eu Fax: +44 20 75 23 70 51
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Taraxacum officinale Weber ex Wigg.; Taraxaci folium; dandelion leaf
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: maN@eiTiea.europa.eu http://www.emea.europa.eu
© European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged
1. NAME OF THE MEDICINAL PRODUCT
To be specified for the individual finished product.
2. Qualitative and quantitative composition1
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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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Taraxacum officinale Weber ex Wigg., folium (dandelion leaf) | |
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i) Herbal substance | |
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Not applicable | |
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ii) Herbal preparations a) Liquid extract (1:1 in 25% ethanol) b) Expressed juice1 2 from fresh Taraxaci folium c) Dried leaves, comminuted |
3. PHARMACEUTICAL FORM
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Well-established use |
Traditional use |
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Herbal preparations in solid or liquid dosage forms or as herbal tea for oral use. | |
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The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
4.1. Therapeutic indications
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Well-established use |
Traditional use Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use. |
4.2. Posology and method of administration
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Well-established use |
Traditional use Posology Adolescents over 12 years of age, adults a) Liquid extract (1:1 in 25% ethanol), 4-10 ml 3 times daily b) Expressed juice from fresh Taraxaci folium, 2 times daliy c) Dried leaves, comminuted: 3 times daily as tea (4-10 g) The use is not recommended in children under 12 years of age (see also 4.4 ‘Special warnings and precautions for use’). Duration of use If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oral use. To ensure an increase of the amount of urine, adequate fluid intake is required during treatment. |
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Well-established use |
Traditional use Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use For extracts containing ethanol 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. The use in adolescents over 12 years of age and adults all with renal failure and/or diabetes, and/or heart failure should be avoided because of possible complications due to hyperkalaemia. The use in children under 12 years of age is not recommended because of the lack of available experience. If complaints or symptoms such as fever, dysuria, spasms or blood in urine occur during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use None reported. |
4.6. Pregnancy and lactation
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Well-established use |
Traditional use Safety during pregnancy and lactation has not been established. In the absence of sufficient data, 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 No studies on the effect on the ability to drive and use machines have been performed. |
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Well-established use |
Traditional use |
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Allergic reactions. 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. Adequate tests on genotoxicity have not been performed. Tests on reproductive toxicity and carcinogenicity have not been performed. |
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Well-established use |
Traditional use |
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Not applicable. |
7. DATE OF COMPILATION/LAST REVISION
14 January 2009
© EMEA 2009 6/6
The declaration of the active substance(s) for an individual finished product should be in relevance with the relevant herbal quality guidance..
The material complies with Ph. Eur. monograph on herbal drugs.