Draft Community Herbal Monograph On Tilia Cordata Miller, Tilia Platyphyllos Scop., Tilia X Vulgaris Heyne Or Their Mixtures, Flos
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
13 September 2011
EMA/HMPC/337066/2011
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Tilia cordata Miller, Tila platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos; Tiliae flos; Lime flower
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Discussion in Working Party on Community monographs and Community |
May 2011 |
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list (MLWP) |
July 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
13 September 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 February 2012 |
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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): .Buna, ^at |
LT (lietuviq. kalba): |
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CS (cestina): Lipovy kvët |
LV (latviesu valoda): Liepu ziedi |
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DA (dansk): Lindeblomst |
MT (malti): |
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DE (Deutsch): Lindenblüten |
NL (nederlands): Lindebloesem |
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EL (ellinika): AvOoç ^lÀÀùpaç |
PL (polski): Kwiat lipy |
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EN (English): Lime flower |
PT (portugues): Tilia, flor |
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ES (espanol): Tilo, flor de |
RO (romånä): Floare de tei |
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ET (eesti keel): Pärnaöis |
SK (slovencina): Lipovy kvet |
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FI (suomi): |
SL (slovenscina): Cvet lipe |
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FR (français): Tilleul (fleur de) |
SV (svenska): Lindblomma |
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HU (magyar): Harsfaviragzat |
IS (íslenska): |
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IT (italiano): Tiglio fiore |
NO (norsk): Lindeblomst |
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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
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 Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, flos or their mixtures (Lime flower) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V c) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 45% V/V |
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 liquid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
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.: 01/2008:0957).
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 used for the relief of symptoms of common cold. Indication 2) Traditional herbal medicinal product for the relief of mild symptoms of mental stress. 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 administration3
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Well-established use |
Traditional use |
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Posology Adolescents, Adults and Elderly a) Comminuted herbal substance Single dose Herbal tea: 1.5 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion 2-4 times daily. b) Liquid extract Single dose 2 ml 1-2 times daily Daily dose 2-4 ml c) Tincture Single dose 1 ml 1-2 times daily Daily dose 1-2 ml The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for 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).
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Well-established use |
Traditional use |
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Duration of use Indication 1) The therapy should start at first signs of common cold. If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Indication 2) If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be 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. |
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. Indication 1) If the symptoms worsen during the use of the medicinal product or if dyspnoea, high fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted immediately. For tinctures and 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. |
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. 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. No fertility data available. |
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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None known. If adverse reactions 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 datai
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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. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
13 September 2011
Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011 Page 7/6