Draft Community Herbal Monograph On Sisymbrium Officinale (L.) Scop., Herba
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 January 2014
EMA/HMPC/280193/2013
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Sisymbrium officinale (L.) Scop., herba
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Sisymbrium officinale (L.) Scop., herba; Sisymbrii officinalis herba; hedge mustard
BG (balgarski): MtApw^ ^ene6Ha, ^at
CS (cestina): kvët hulevníku lékarského
DA (dansk): rank vejsennep
DE (Deutsch): Wegraukenkraut
EL (elliniká): Ziaupßpiou ^appaKEUTiKOÙ àv0oç
EN (English): hedge mustard
ES (espanol): Erísimo, partes aéreas floridas de
ET (eesti keel): uniloogaürt
FI (suomi): rohtopernaruoho, verso
FR (français): Erysimum (parties aériennes
fleuries d')
HU (magyar): szapora zsombor HR (hrvatska): zelen divlje gorusice IT (italiano): erisimo, parti aeree_
LT (lietuviq kalba): vaistiniq pikuliq ziedai
LV (latviesu valoda): ärstniedbas zodzenes ziedi
MT (malti): mustarda
NL (nederlands): heeskruid
PL (polski): kwiat stulisza lekarskiego
PT (portugués): rinchao flor
RO (romana):
SK (slovencina): vnat' horcicníka SL (slovenscina): cved navadnega sebenika SV (svenska): vägsenap IS (íslenska):
NO (norsk): veisennep
Draft
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Discussion in Working Party on Community monographs and Community list (MLWP) |
January 2012 May 2013 July 2013 September 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 November 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 April 2013 |
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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, 2014. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Sisymbrium officinale (L.) Scop., herba
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 Sisymbrium officinale (L.) Scop., herba (hedge mustard) i) Herbal substance Not applicable. ii) Herbal preparations a) Dry extract (DER 3.5-5.5:1), extraction solvent water b) Dry extract (DER 6-8:1), extraction solvent water |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparations for oromucosal use (in a solid dosage form). Herbal preparation for oral use (in a liquid dosage form). The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The material complies with the French Pharmacopoeia monograph (Pharmacopée française 1998 Érysimum, Sisymbrium officinale)
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 the relief of throat irritation such as hoarseness and dry cough. The product is a traditional herbal medicinal product for use in the 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 Single dose Oromucosal use Adolescents, adults and elderly a) Dry extract (DER 3.5-5.5:1), extraction solvent water: 10 mg, 10 - 12 times daily b) Dry extract (DER 6-8:1), extraction solvent water: 7.5 - 10 mg, 10 - 12 times daily Children 6 - 11 years of age a) Dry extract (DER 3.5-5.5:1), extraction solvent water: 10 mg, 5 - 6 times daily b) Dry extract (DER 6-8:1), extraction solvent water: 7.5 - 10 mg, 5 - 6 times daily The oromucosal use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Tablet/lozenge to dissolve in the mouth without chewing. Oral use Adolescents, adults and elderly b) Dry extract (DER 6-8:1), extraction solvent water: 82.5 mg, 3 - 4 times daily Children 3 - 11 years of age b) Dry extract (DER 6-8:1), extraction solvent water: 27.5 mg, 3 - 4 times daily The oral use in children under 3 years of age is not |
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Well-established use |
Traditional use |
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recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use 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. Method of administration Oral use. Oromucosal 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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If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted immediately. Herbal preparations a) and b) The oromucosal use in children under 6 years of age is not recommended because of the pharmaceutical form (solid dosage form) and due to lack of adequate data. Herbal preparation b) The oral use in children under 3 years of age is not recommended due to lack of adequate data and because medical advice should be sought. |
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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Not known. |
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 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
15 January 2014
Page 6/6
Community herbal monograph on Sisymbrium officinale (L.) Scop., herba
EMA/HMPC/280193/2013