Draft European Union Herbal Monograph On Origanum Majorana L., Herba
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
2 February 2016
EMA/HMPC/166517/2015
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Origanum
majorana L., herba
Draft
An agency of the European Union
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Discussion in Working Party on European Union monographs and list (MLWP) |
November 2014 January 2015 March 2015 May 2015 July 2015 November 2015 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
02 February 2016 |
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Start of public consultation |
15 February 2016 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 May 2016 |
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Re-discussion in MLWP | |
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Adoption by HMPC |
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Keywords |
Herbal medicinal products; HMPC; European Union herbal monographs; |
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traditional use; Origanum majorana L., herba; Origani majoranae herba; | |
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Majoram |
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BG (bulgarski): MafiopaHa, CTptK |
LT (lietuviq kalba): Kvapij mairnnq zolé |
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CS (cestina): dobromyslová nat' |
LV (latviesu valoda): Majorana laksts |
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DA (dansk): Havemerian |
MT (Malti): haxixa tal-Merdqux |
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DE (Deutsch): Majorankraut |
NL (Nederlands): Echte marjolein, kruid |
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EL (elliniká): nóa opÍYavov to apàpaKOv |
PL (polski): Ziele majeranku |
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EN (English): Majoram |
PT (portugués): Manjerona |
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ES (español): Mejorana, partes aéreas de |
RO (romana): iarba de maghiran |
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ET (eesti keel): majoraaniürt |
SK (slovencina): Vñat' majoránu záhradného |
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FI (suomi): maustemeirami, verso |
SL (slovenScina): zel majarona |
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FR (français): Marjolaine (sommité fleurie de) |
SV (svenska): Mejram, ört |
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HR (hrvatski): mazuranova zelen |
IS (íslenska): |
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HU (magyar): majoránna virágos hajtás IT (italiano): Maggiorana parti aeree fiorite |
NO (norsk): Merian |
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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
European Union herbal monograph on Origanum majorana L., 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 Origanum majorana, herba (Majoram) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Extract3 (ratio of herbal substance to extraction solvent 1:5), extraction solvents ethanol 96% V/V and white petroleum jelly. |
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 semi-solid dosage forms for cutaneous 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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Indication 1) Traditional herbal medicinal product used for the symptomatic relief of mild spasmodic gastrointestinal complaints such as bloating and flatulence. Indication 2) Traditional herbal medicinal product used for relief of irritated skin around the nostrils. The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use. |
4.2. Posology and method of administration4
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Well-established use |
Traditional use |
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Posology |
Posology Indication 1) Adults and elderly a) Herbal tea: 1-2 g of the comminuted herbal substance in one cup (150 ml) boiling water as herbal infusion, one cup, before meals. Daily dose: 3-6 g Indication 2) Herbal preparation b) Children 1-11 years, adolescents and adults Small amount of the preparation spread around nostrils, 2 to 4 times daily (see section 4.4 'Special warnings and precautions for use'). Duration of use Indication 1) If the symptoms persist after 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be |
4 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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consulted. Indication 2) If the symptoms persist after 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted Method of administration Preparation a) Oral use. Preparation b) Cutaneous use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance or to other plants of the Lamiaceae family. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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Indication 1) The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. Indication 2) The use in children under 1 year of age has not been established due to lack of adequate data. The deep penetration of the ointment inside nostril should be avoided, as it can reduce the activity of the ciliary epithelium If signs of skin infection are observed during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Eye contact with unwashed hands after the application may potentially cause irritation. |
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Well-established use |
Traditional use |
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Indication 1) and 2) If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. |
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 ability to drive or 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 data4
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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
2 February 2016
Page 6/6
European Union herbal monograph on Origanum majorana L., herba
EMA/HMPC/166517/2015
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
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.
The preparation is described in the Farmakopea Polska (1995), two parts of comminuted Origanum majorana L., herba is moistened with one part of ethanol 96% and then warm extracted with ten parts of white petroleum jelly until ethanol evaporation.
Where herbal preparations from Origani majoranae herba are used, the total exposure to hydroquinone derivatives should be considered from a safety standpoint.