Draft Community Herbal Monograph On Fraxinus Excelsior L. And Fraxinus Angustifolia Vahl, Folium
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 July 2011
EMA/HMPC/239271/2011
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium; ash leaf
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Discussion in Working Party on Community monographs and Community |
March 2011 |
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list (MLWP) |
May 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 July 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 November 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): flceH, nucr |
LT (lietuviq. kalba): |
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CS (cestina): jasanovy list |
LV (latviesu valoda): Osa lapas |
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DA (dansk): Askeblad |
MT (malti): |
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DE (Deutsch): Eschenblätter |
NL (nederlands): Es |
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EL (ellinika): |
PL (polski): Lisc jesionu |
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EN (English): ash leaf |
PT (portugues): Freixo, folha |
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ES (espanol): Fresno, hoja de |
RO (romånä): frunzä de frasin |
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ET (eesti keel): saareleht |
SK (slovencina): Jasenovy list |
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FI (suomi): |
SL (slovenScina): list velikega jesena |
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FR (français): Frêne (feuille de) |
SV (svenska): Askblad |
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HU (magyar): Körisfa levél |
IS (íslenska): |
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IT (italiano): Frassino foglia |
NO (norsk): Askeblad |
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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
Name of the medicinal product
To be specified for the individual finished product.
1. 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 Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium (ash leaf) i) Herbal substance Not applicable. ii) Herbal preparations Comminuted herbal substance |
2. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea (decoction or infusion) for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
3. Clinical particulars
3.1. Therapeutic indications
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Well-established use |
Traditional use |
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Indication 1) Traditional herbal medicinal product used for relief of minor articular pain. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1600)._
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
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Well-established use |
Traditional use |
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Indication 2) Traditional herbal medicinal product used 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 indications exclusively based upon long-standing use. |
3.2. Posology and method of administration3
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Well-established use |
Traditional use |
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Posology Adults and elderly Average daily dose: Herbal tea: 20 g of comminuted herbal substance in 1000 ml of water as a decoction, divided in 2-3 single doses. Herbal tea: 10-30 g of comminuted herbal substance in 1000 ml of boiling water as a herbal infusion, divided in 2-3 single doses. The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use Indication 1) If the symptoms persist longer than 4 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indication 2) 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. |
3 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC 'Glossary on herbal teas' (EMA/HMPC/5829/2010 Rev.1)._
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
3.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s). Condition where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease). |
3.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The use in children and adolescents under 18 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. Indication 1) Articular pain accompanied by swelling of joints, redness or fever should be examined by a doctor. Indication 2) If minor urinary tract complaints worsen and symptoms such as fever, dysuria, spasm, or blood in the urine occur during the use of medicinal product, a doctor or a qualified health care professional should be consulted. To ensure an increase of the amount of urine, adequate fluid intake is required during treatment. |
3.5. 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. |
3.6. 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 and lactation is not recommended. |
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
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Well-established use |
Traditional use |
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No fertility data available. |
3.7. 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. |
3.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. |
3.9. Overdose
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Well-established use |
Traditional use |
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No case of overdose has been reported. |
4. Pharmacological properties
4.1. 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. |
4.2. 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. |
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
EMA/HMPC/239271/2011
4.3. 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. |
5. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
6. Date of compilation/last revision
12 July 2011
Community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium
EMA/HMPC/239271/2011
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