Draft Community Herbal Monograph On Oenothera Biennis L.; Oenothera Lamarckiana L., Oleum
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
31 March 2011
EMA/HMPC/277792/2009
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use Oenothera biennis L.; Oenothera lamarckiana L., oleum; evening primrose oil
BG (balgarski): nynama, Macno CS (cestina): pupalkovy olej DA (dansk): Kæmpenatlysolie DE (Deutsch): Nachtkerzensamenöl EL (ellinika): Oivo0gpaç eÀaio EN (English): evening primrose oil ES (espanol): Onagra, aceite de ET (eesti keel): kaheaastase kuningakepi öli FI (suomi):
FR (français): Onagre (huile d')
HU (magyar): Ligetszépe-olaj
IT (italiano): Enotera olio_
LT (lietuviq kalba):
LV (latviesu valoda): DivgadTgäs naktssveces ejja
MT (malti): Zejt tal-Oenotheria
NL (nederlands): Teunisbloemolie
PL (polski): Olej wiesiolkowy
PT (portugués): Óleo de onagra
RO (romana): ulei de lumini^a nop^ii
SK (slovencina): Pupalkovy olej
SL (slovenscina): olje dvoletnega svetlina
SV (svenska): Passionsblomma
IS (íslenska):
NO (norsk): Pasjonsblomst
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Discussion in Working Party on Community monographs and Community list (MLWP) |
March 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
31 March 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 August 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 Oenothera biennis L.; Oenothera lamarckiana L., oleum
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 |
|
With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended | |
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Oenothera biennis L.; Oenothera lamarckiana L., oleum (evening primrose oil) | |
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i) Herbal substance | |
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Not applicable. | |
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ii) Herbal preparations | |
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Fatty oil obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction and/or expression. |
3. Pharmaceutical form
|
Well-established use |
Traditional use |
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Herbal preparation in solid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 01/2010:2104)._
4. Clinical particulars
4.1. Therapeutic indications
|
Well-established use |
Traditional use |
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Traditional herbal medicinal product for the symptomatic relief of itching in acute and chronic dry skin conditions. |
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: 2 g Daily dose: 4-6 g 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 8 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. |
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 been established due to lack of adequate 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. |
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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Gastrointestinal effects, indigestion, nausea, softening of stool, rise in temperature, hypersensitive reactions like exanthema and headache 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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The symptoms of overdosing are mild diarrhoea and abdominal pain. No special treatment is required. |
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
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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, 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
31 March 2011
Page 6/5
Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L.,
oleum
EMA/HMPC/277792/2009