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Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU)
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- 2011 No. 785
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Changes over time for: Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU) (Annexes only)
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There are currently no known outstanding effects for the Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU).
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ANNEXU.K.
Annexes I and II to Decision 2008/911/EC are amended as follows:
1.
in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit):
‘Hamamelis virginiana L., folium et cortex aut ramunculus destillatum’;
2.
in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus:
‘COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM
Scientific name of the plant
Hamamelis virginiana L.
Botanical family
Hamamelidaceae
Herbal preparation(s)
1.
Distillate prepared from fresh leaves and bark (1:1.12 – 2.08; extraction solvent ethanol 6 % m/m)
2.
Distillate prepared from dried twigs (1:2; extraction solvent ethanol 14-15 %)(1)
European pharmacopoeia monograph reference
Not applicable
Indication(s)
Indication (a)
Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.
Indication (b)
Traditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Type of tradition
European
Specified strength
Please see ‘Specified posology’.
Specified posology
Children over six years of age, adolescents, adults and elderly
Indication (a)
Distillate in a strength corresponding to 5-30 % in semi-solid preparations, several times daily.
The use in children under six years of age is not recommended (see section ‘Special warnings and precautions for use’).
Adolescents, adults and elderly
Indication (b)
Eye drops(2) Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 times daily.
The use in children under 12 years of age is not recommended (see section ‘Special warnings and precautions for use’).
Route of administration
Cutaneous use.
Ocular use.
Duration of use or any restrictions on the duration of use
Children over six years of age, adolescents, adults and elderly
Indication (a)
If the symptoms persist longer than two weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Adolescents, adults and elderly
Indication (b)
The recommended duration of use is four days. If the symptoms persist longer than two days during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Any other information necessary for the safe use
Contraindications
Hypersensitivity to the active substance.
Special warnings and precautions for use
Indication (a)
The use in children under six years of age has not been established due to lack of adequate data.
Indication (b)
If eye pain, changes in vision, continued redness, or irritation of the eye is experienced, or if the condition worsens or persists for more than 48 hours during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
The use in children under 12 years of age has not been established due to lack of adequate data.
For extracts containing ethanol, the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the label and package leaflet of medicinal products for human use’, must be included.
Interactions with other medicinal products and other forms of interaction
None reported.
Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
Indication (a)
Allergic contact dermatitis may occur in sensitive patients. The frequency is not known.
Indication (b)
Conjunctivitis cases have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
Overdose
No case of overdose has been reported.
Pharmaceutical particulars [if necessary]
Not applicable.
Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [if necessary for the safe use of the product]
Not applicable.’.
(1)
According to USP (USP-31- NF 26, 2008 Vol 3:3526).
(2)
The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163).’.
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