Draft Community Herbal Monograph On Cinnamomum Verum J.S. Presl (Cinnamomum Zeylanicum Nees), Aetheroleum
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 July 2010
EMA/HMPC/706229/2009
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Cinnamomum verum J.S. Presl., aetheroleum; Cinnamomi corticis aetheroleum; Cinnamon bark oil
BG (bälgarski):
CS (Cestina):
DA (dansk): Ceylonkanel barkolie DE (Deutsch): Zimtöl EL (ellinika):
EN (English):
ES (espanol):
ET (eesti keel):
FI (suomi):
FR (français): Cannelle de Ceylan (huile essentielle de)
HU (magyar): ceyloni fahéjfa kéreg olaj IT (italiano):_
LT (lietuviq kalba):
LV (latviesu valoda): Kanejkoka eteriska ejja MT (malti):
NL (nederlands):
PL (polski):
PT (portugués): Óleo essencial de canela de Ceilao
RO (romana):
SK (slovencina): Skoricovníková silica SL (slovenscina):
SV (svenska):
IS (íslenska):
NO (norsk): kanelolje_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
November 2009 May 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
15 July 2010 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 December 2010 |
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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, 2010. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum
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. Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), aetheroleum corticis (cinnamon bark oil) i) Herbal substance Not applicable ii) Herbal preparations Essential oil obtained by steam distillation from the cortex |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparation in liquid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1501).
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
|
Well-established use |
Traditional use |
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Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence. The product is a traditional herbal medicinal product for use in a 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 Adults and elderly Essential oil: 50 to 200 mg daily, in 2 to 3 doses. In order to avoid local irritation, the use of the undiluted oil is not recommended. The use in children and adolescents under 18 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
|
Well-established use |
Traditional use |
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Hypersensitivity to the active substance or to Peru balsam. |
4.4. Special warnings and precautions for use
|
Well-established use |
Traditional use |
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The use in children and adolescents under 18 years of age has not 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 professional should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
|
Well-established use |
Traditional use |
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None reported. |
4.6. Pregnancy and lactation
|
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
|
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
|
Well-established use |
Traditional use |
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Local irritation of the oral mucosa has 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
|
Well-established use |
Traditional use |
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No case of overdose has been reported. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
|
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
|
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, 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 July 2010
Page 5/5
Community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum
zeylanicum Nees), aetheroleum
EMA/HMPC/706229/2009