Draft European Union Herbal Monograph On Glycine Max (L.) Merr., Lecithin
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 July 2016 EMA/HMPC/220599/2016
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Glycine max (L.) Merr., lecithin
Draft
Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Glycine max (L.) Merr., lecithin; Lecithinum ex soya; soyabean lecithin
BG (bulgarski): CoeB ne^TMH
CS (cestina): sójovy lecithin
DA (dansk): Sojalecithin
DE (Deutsch): Sojabohnen, Phospholipide aus
Sojabohnen
EL (ellinika): AeKiOivp anó aÓYia EN (English): soya-bean lecithin ES (espanol): Lecitina de soja ET (eesti keel): sojaletsitiin FI (suomi): soija, lesitiini FR (français):
HR (hrvatski): Sojin lecitin HU (magyar): szójalecitin
IT (italiano): lecitina di soia LT (lietuviq. kalba): Sojq. lecitinas LV (latviesu valoda):
MT (Malti): Lecitina tas-sojja NL (Nederlands):
PL (polski): Lecytyna sojowa PT (portugues): Lecitina de soja RO (romana): soia, lecitina SK (slovencina): sója fazul'ova, lecitin SL (slovenscina): lecitin iz soje SV (svenska): sojalecitin IS (islenska):
NO (norsk): Soyalecitin
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Discussion in Working Party on European Union monographs and list (MLWP) |
March 2014 November 2015 April 2016 May/June 2016 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 July 2016 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu. |
31 October 2016 |
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Re-discussion in MLWP | |
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Adoption by HMPC |
Keywords
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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
European Union herbal monograph on Glycine max (L.) Merr., lecithin
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 Glycine max (L.) Merr., lecithin (soya-bean lecithin) i) Herbal substance Not applicable ii) Herbal preparations Soya-bean lecithin (deoiled, enriched phospholipids from soya bean) |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparations in liquid or 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 the relief of temporary fatigue and sensation of weakness. The product is a traditional herbal medicinal product for use in the specified indication |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2 Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a Member State.
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Well-established use |
Traditional use |
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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: 750 - 2700 mg, 2-3 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 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 |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance, soya, peanut and to other plants of the Fabaceae (legume) family and to birch pollen. Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.3 |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. The use in children under 12 years of age has not been established due to lack of adequate |
In accordance with the 'Public statement on the allergenic potency of herbal medicinal products containing soya or peanut protein' (EMA/HMPC/138139/2005).
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Well-established use |
Traditional use |
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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. 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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Soya lecithin has no or negligible influence on the ability to drive and use machines. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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Allergic reactions including severe anaphylaxis and angioedema have been reported. The frequency is not known. Skin reactions like pruritus, dermatitis, exanthema and urticaria have been reported. The frequency is not known. Gastrointestinal disorders like stomach discomfort and diarrhoea have been reported. 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 reproductive toxicity and genotoxicity have not been performed. Tests on 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
12 July 2016
European Union herbal monograph on Glycine max (L.) Merr., lecithin
EMA/HMPC/220599/2016
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