COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Granufink Vescica». (15A08550)
Estratto determina V&A n. 2020/2015 del 20 ottobre 2015 Descrizione del medicinale e attribuzione n. A.I.C. e' autorizzata l'immissione in commercio del medicinale: «GRANUFINK VESCICA», nella forma e confezione: «capsula rigida» 50 capsule in blister PVC/AL alle condizioni e con le specificazioni di seguito indicate: Titolare A.I.C.: Skillpharma S.r.l. con sede legale e domicilio fiscale in via Umberto Saba n. 4, 00144 Roma, codice fiscale n. 08522931008;
Confezione: «capsula rigida» 50 capsule in blister PVC/AL - A.I.C. n. 043180013 (in base 10) 195RZF (in base 32). Forma farmaceutica: capsula rigida. Validita' prodotto integro: 3 anni dalla data di fabbricazione. Produttore del principio attivo: semi di zucca schiacciati: Omega Pharma Manufacturing GmbH &
Co. KG stabilimento sito in Benzstr. 25, D-71083 Herrenberg, Germania (produzione, controllo e rilascio);
olio di semi di zucca: Estyria Naturprodukte GmbH stabilimento sito in Wollsdorf 75, 8181 St. Ruprecht/Raab - Austria (estrazione dell'olio);
Omega Pharma Manufacturing GmbH &
Co. KG stabilimento sito in Benzstr. 25, D-71083 Herrenberg, Germania (controllo e rilascio dell'olio);
Produttore del prodotto finito: Omega Pharma Manufacturing GmbH &
Co. KG stabilimento sito in Benzstr. 25, D-71083 Herrenberg, Germania (produzione, confezionamento primario e secondario, controllo e rilascio dei lotti;
Composizione: una capsula rigida contiene;
Principio Attivo: semi di zucca schiacciati 400 mg;
olio di semi di zucca 340 mg;
Eccipienti: gelatina;
ossido di ferro rosso (E172);
diossido di titanio (E171);
Indicazioni terapeutiche: Granufink Vescica e' un medicinale tradizionale di origine vegetale utilizzato per il sollievo dei sintomi delle basse vie urinarie collegati a vescica iperattiva, dopo che il medico abbia escluso la presenza di condizioni gravi. L'impiego di questo medicinale vegetale tradizionale, per le indicazioni terapeutiche indicate, si basa esclusivamente sull'esperienza di...
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