COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Bosentan Zentiva» (18A05244)
Estratto determina n. 1118/2018 del 13 luglio 2018 Medicinale: BOSENTAN ZENTIVA. Titolare AIC: Zentiva Italia S.r.l. La nuova indicazione terapeutica del medicinale: «Bosentan Zentiva e' anche indicato per ridurre il numero di nuove ulcere digitali in pazienti con sclerosi sistemica e ulcere digitali attive»;
e' rimborsata come segue: Confezioni: «62,5 mg compresse rivestite con film» 56 compresse in blister PVC/PE/PVDC/AL - A.I.C. n. 042243028 (in base 10). Classe di rimborsabilita': A. Prezzo ex factory (IVA esclusa): €
354,48. Prezzo al pubblico (IVA inclusa): €
664,82. «62,5 mg compresse rivestite con film» 56 compresse in blister OPA/AL/PVC/AL - A.I.C. n. 042243055 (in base 10). Classe di rimborsabilita': A. Prezzo ex factory (IVA esclusa): €
354,48. Prezzo al pubblico (IVA inclusa): €
664,82. «125 mg compresse rivestite con film» 56 compresse in blister PVC/PE/PVDC/AL - A.I.C. n. 042243081 (in base 10). Classe di rimborsabilita': A. Prezzo ex factory (IVA esclusa): €
354,48. Prezzo al pubblico (IVA inclusa): €
664,82. «125 mg compresse rivestite con film» 56 compresse in blister OPA/AL/PVC/AL - A.I.C. n. 042243117 (in base 10). Classe di rimborsabilita': A. Prezzo ex factory (IVA esclusa): €
354,48. Prezzo al pubblico (IVA inclusa): €
664,82. Validita' del contratto: 24 mesi. Condizioni e modalita' di impiego Prescrizione del medicinale soggetta a diagnosi - secondo quanto previsto dall'allegato 2 e successive modifiche della determina 29 ottobre 2004 - PHT Prontuario della distribuzione diretta -, pubblicata nel supplemento ordinario alla Gazzetta Ufficiale n. 259 del 4 novembre 2004. Classificazione ai fini della fornitura La classificazione ai fini della...
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