
Article 1 
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 3 February 2012.
For the Commission
John DALLI
Member of the Commission
ANNEX

Decision 2008/911/EC is amended as follows:

((1)) in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:
'Vitis vinifera L., folium'
((2)) in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.:
'
Vitis vinifera L.

Vitaceae

Grapevine leaf


 BG (bălgarski): лоза, лист
 CS (čeština): Červený list vinné révy
 DA (dansk): Vinblad
 DE (Deutsch): Rote Weinrebenblätter
 EL (elliniká): Φύλλο Αμπέλου
 EN (English): Grapevine leaf
 ES (español): Vid, hoja de
 ET (eesti keel): Viinapuu lehed
 FI (suomi): Aitoviiniköynnös, lehti
 FR (français): Feuille de vigne rouge
 HU (magyar): Bortermő szőlő levél
 IT (italiano): Vite, foglia
 LT (lietuvių kalba): Tikrųjų vynmedžių lapai
 LV (latviešu valoda): Īstā vīnkoka lapas
 MT (malti): Werqa tad-dielja
 NL (nederlands): Wijnstokblad
 PL (polski): Liść winorośli właściwej
 PT (português): Folha de videira
 RO (română): Frunze de viță-de-vie
 SK (slovenčina): List viniča
 SL (slovenščina): List vinske trte
 SV (svenska): Blad från vinranka
 IS (íslenska): Vínviðarlauf
 NO (norsk): Rød vinranke, blad

Soft extract (2.5-4:1; extraction solvent water)

Not applicable

Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.

The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

European

Please see “Specified posology”.

Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract).

Apply a thin layer on the affected area 1-3 times daily.

The use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”).

Cutaneous use.

The recommended duration of use is 4 weeks.

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.

Hypersensitivity to the active substance.

If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.

The product should not be used on broken skin, around the eyes or on mucous membranes.

In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended.

None reported.

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 studies on the effect on the ability to drive and use machines have been performed.

Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) 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.

No case of overdose has been reported.

Not applicable.

Not applicable.
'
