2008/911/EC: Commission Decision of 21 November 2008 establishing of a list of he... (32008D0911)
2008/911/EC: Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance)
- COMMISSION DECISION
- of 21 November 2008
- establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
- (notified under document number C(2008) 6933)
- (Text with EEA relevance)
- (2008/911/EC)
- Article 1
- Article 2
- Article 3
- ANNEX I
- List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC
- ANNEX II
- A. COMMUNITY LIST ENTRY ON
- FOENICULUM VULGARE
- MILLER SUBSP.
- VULGARE
- VAR.
- VULGARE
- , FRUCTUS
- Scientific name of the plant
- Botanical family
- Herbal substance
- Common name in all EU official languages of herbal substance
- Herbal preparation(s)
- European Pharmacopoeia monograph reference
- Indication(s)
- Type of tradition
- Specified strength
- Specified posology
- Adults
- Adolescents over 12 years of age,
- indication (a)
- Children between four and 12 years of age,
- indication (a)
- Route of administration
- Duration of use or any restrictions on the duration of use
- Adults
- Adolescents over 12 years of age,
- indication (a)
- Children between four and 12 years of age,
- indication (a)
- Any other information necessary for the safe use
- Contraindications
- Special warnings and precautions for use
- Interactions with other medicinal products and other forms of interaction
- Pregnancy and lactation
- Effects on ability to drive and use machines
- Undesirable effects
- Overdose
- Pharmaceutical particulars
- (if necessary)
- Pharmacological effects or efficacy plausible on the basis of long-standing use and experience
- (if necessary for the safe use of the product)
- B. COMMUNITY LIST ENTRY ON
- FOENICULUM VULGARE
- MILLER SUBSP.
- VULGARE
- VAR.
- DULCE
- (MILLER) THELLUNG, FRUCTUS
- Scientific name of the plant
- Botanical family
- Herbal substance
- Common name in all EU official languages of herbal substance
- Herbal preparation(s)
- European Pharmacopoeia monograph reference
- Indication(s)
- Type of tradition
- Specified strength
- Specified posology
- Adults
- Adolescents over 12 years of age,
- indication (a)
- Children between four and 12 years of age,
- indication (a)
- Route of administration
- Duration of use or any restrictions on the duration of use
- Adults
- Adolescents over 12 years of age,
- indication (a)
- Children between four and 12 years of age,
- indication (a)
- Any other information necessary for the safe use
- Contraindications
- Special warnings and precautions for use
- Interactions with other medicinal products and other forms of interaction
- Pregnancy and lactation
- Effects on ability to drive and use machines
- Undesirable effects
- Overdose
- Pharmaceutical particulars
- (if necessary)
- Pharmacological effects or efficacy plausible on the basis of long-standing use and experience
- (if necessary for the safe use of the product)
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