COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Darilin». (15A02472)
Estratto determina n. 121/2015 dell'11 febbraio 2015 Medicinale: DARILIN. Titolare A.I.C.: Recordati Industria Chimica e Farmaceutica S.P.A. Classificazione ai fini della rimborsabilita' La nuova posologia e modo di somministrazione: Prevenzione della malattia da CMV nel trapianto di organo solido: Per i pazienti sottoposti a trapianto di rene, la dose raccomandata e' di 900 mg (due compresse di Darilin da 450 mg) una volta al giorno, iniziando entro 10 giorni dal trapianto e proseguendo fino a 100 giorni dopo il trapianto. Si puo' continuare la profilassi fino a 200 giorni dopo il trapianto (vedere paragrafi 4.4, 4.8 e 5.1) del medicinale Darlin e' rimborsata come segue: Confezione: 60 compresse rivestite con film da 450 mg - A.I.C. n. 035740012 (in base 10) 122QCD (in base 32). Classe di rimborsabilita': A. Prezzo ex factory (IVA esclusa): €
1326,95. Prezzo al pubblico (IVA inclusa): €
2190,00. Validita' del contratto: 12 mesi. Sconto obbligatorio alle strutture pubbliche sul prezzo Ex Factory come da condizioni negoziali. Classificazione ai fini della fornitura La...
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