Draft Community Herbal Monograph On Lavandula Angustifolia P. Mill., Flos
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
27 January 2011
EMA/HMPC/734125/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Lavandula angustifolia P. Mill., flos
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Lavandula angustifolia P. Mill., flos; Lavandulae flos; lavender flower
BG (balgarski): ^aBaHflyna, ^at CS (cestina): levandulovy kvët DA (dansk):
DE (Deutsch): Lavendelblüten EL (ellinika):
EN (English): lavender ES (espanol):
ET (eesti keel): tähklavendli öis FI (suomi):
FR (français): lavande (fleur de) HU (magyar): Levendulavirag IT (italiano):_
LT (lietuviq kalba):
LV (latviesu valoda): Lavandas ziedi MT (malti):
NL (nederlands):
PL (polski): Kwiat lawendy PT (portugués):
RO (romana): floare de levänjicä SK (slovencina): Levandul'ovy kvet SL (slovenscina):
SV (svenska): Lavendelblomma IS (íslenska):
NO (norsk): lavendelblomst
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Discussion in Working Party on Community monographs and Community list (MLWP) |
November 2010 January 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
27 January 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 Aug 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.
Community herbal monograph on Lavandula angustifolia P. Mill., 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 Lavandula angustifolia P. Mill., flos (lavender flower) i) Herbal substance As defined in the Ph. Eur. monograph. ii) Herbal preparations a) Comminuted herbal substance b) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 50-60% v/v |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal substance or comminuted herbal substance as herbal tea for oral use. Herbal preparations in liquid dosage form for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1534).
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 relief of mild symptoms of mental stress and exhaustion and to aid sleep. 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 |
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Posology Adolescents, adults and elderly a) An infusion is made of herbal substance or comminuted herbal substance (approximately 1 to 2 g) in 150 ml of water: 3 times daily b) Tincture Single dose: 2-4 ml, 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 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(s). |
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 |
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Well-established use |
Traditional use |
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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. For tinctures 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. 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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May impair ability to drive and use machines. Affected patients should not drive or operate machinery. 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 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
27 January 2011
Page 5/5
Community herbal monograph on TLavandula angustifolia P. Mill., flos
EMA/734125/2010