COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Vitis Vinifera Yes Pharma». (17A06163)
Estratto determina AAM/AIC n. 110/2017 del 1° agosto 2017 Procedura europea n. AT/H/0647/001/DC;
Descrizione del medicinale e attribuzione n. A.I.C. E' autorizzata l'immissione in commercio del medicinale: VITIS VINIFERA YES PHARMA, nelle forme e confezioni, alle condizioni e con le specificazioni di seguito indicate: Titolare A.I.C.: Yes Pharmaceutical Development Services GMBH con sede legale e domicilio fiscale in Bahnstrasse 42-46 - 61381 Friedrichsdorf, Germania. Confezione: «granulato per soluzione orale» 30 bustine in carta/AL - A.I.C. n. 044519015 (in base 10) 1BGMM7 (in base 32). Forma farmaceutica: granulato per soluzione orale. Validita' prodotto integro: tre anni. Composizione: principio attivo: una bustina contiene 360 mg di estratto (sotto forma di estratto secco) di Vitis vinifera L. folium (foglie di vite) (DER 4-6:1), solvente estraente: acqua. eccipienti: Maltodestrina - Acido tartarico - Silice colloidale anidra - Sucralosio. Produttori del principio attivo: Finzelberg GmbH &
Co KG - Koblenzer Straße 48-56 - 56626 Andernach, Germania. Produttori del prodotto finito: Hermes Pharma Ges.m.b.H - Allgäu 36- 9400 Wolfsberg, Austria (produzione, confezionamento primario e secondario, controllo di qualita', rilascio dei lotti). Indicazioni terapeutiche: Vitis vinifera YES Pharma e' un medicinale di origine vegetale per il trattamento dei sintomi dell'insufficienza venosa cronica negli adulti (come gambe gonfie, sensazione di pesantezza, dolore, stanchezza, prurito, tensione e crampi ai polpacci). Classificazione ai fini della rimborsabilita' Per tutte le confezioni sopracitate e' adottata la seguente classificazione ai fini della rimborsabilita': classe di rimborsabilita': Classe C. Classificazione ai fini della fornitura Per tutte le confezioni sopracitate e' adottata la seguente classificazione ai fini della fornitura: SOP: medicinale non soggetto a prescrizione medica ma non da banco. Stampati Le confezioni del medicinale devono essere poste in commercio con etichette e fogli illustrativi conformi al testo allegato alla determinazione, di cui al presente estratto. E' approvato il riassunto delle caratteristiche del prodotto allegato alla...
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