COMUNICATO - Rinnovo dell''autorizzazione alla procedura di mutuo riconoscimento del medicinale «Finasteride Eg». (12A09919)
Estratto determinazione V & A n. 1131 del 22 agosto 2012
Specialita' medicinale: FINASTERIDE EG.
Confezioni:
037837010/M - «5 mg compresse rivestite con film» 10 compresse in blister PVC/PVDC/AL;
037837022/M - «5 mg compresse rivestite con film» 15 compresse in blister PVC/PVDC/AL;
037837034/M - «5 mg compresse rivestite con film» 20 compresse in blister PVC/PVDC/AL;
037837046/M - «5 mg compresse rivestite con film» 28 compresse in blister PVC/PVDC/AL;
037837059/M - «5 mg compresse rivestite con film» 30 compresse in blister PVC/PVDC/AL;
037837061/M - «5 mg compresse rivestite con film» 50 compresse in blister PVC/PVDC/AL;
037837073/M - «5 mg compresse rivestite con film» 50x1 compresse in blister PVC/PVDC/AL;
037837085/M - «5 mg compresse rivestite con film» 60 compresse in blister PVC/PVDC/AL;
037837097/M - «5 mg compresse rivestite con film» 98 compresse in blister PVC/PVDC/AL;
037837109/M - «5 mg compresse rivestite con film» 100 compresse in blister PVC/PVDC/AL;
037837111/M - «5 mg compresse rivestite con film» 100x1 compresse in blister PVC/PVDC/AL;
037837123/M - «5 mg compresse rivestite con film» 30 compresse in flaconi HDPE;
037837135/M - «5 mg compresse rivestite con film» 100 compresse in flaconi HDPE.
Titolare A.I.C.: EG S.P.A.
Numeri procedura mutuo riconoscimento:
SE/H/0666/001/R/001;
SE/H/0666/001/1B/018.
Tipo di modifica: rinnovo autorizzazione.
Modifica apportata: e' autorizzata la modifica del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo e delle etichette. Ulteriori modifiche apportate a seguito della procedura di rinnovo europeo. Gli stampati corretti ed approvati sono allegati alla determinazione.
In ottemperanza all'art. 80 commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modifiche e...
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