COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Niuliva» (19A05803)
Estratto determina n. 1336/2019 del 6 settembre 2019 Medicinale: NIULIVA (Immunoglobulina anti-epatite B) Titolare A.I.C.: Instituto Grifols, S.A. - Can Guasch, 2 - Parets del Valles - 08150 Barcelona - Spagna. Classificazione ai fini della rimborsabilita' La nuova indicazione terapeutica del medicinale «Niuliva» (Immunoglobulina anti-epatite B): «Prevenzione della reinfezione da virus dell'epatite B (HBV) dopo trapianto di fegato per insufficienza epatica da epatite B in pazienti senza replicazione virale attiva prima del trapianto. Immunoprofilassi dell'epatite B In caso di esposizione accidentale in soggetti non immunizzati (incluse le persone con stato vaccinale incompleto o sconosciuto). In pazienti in emodialisi, fino a quando la vaccinazione non diventi efficace. In neonati da madri portatrici del virus dell'epatite B. In soggetti che dopo la vaccinazione non hanno mostrato una risposta immune (anticorpi anti HB non misurabili) e per coloro i quali necessitano di una prevenzione continua, dato il rischio costante di essere infettati da epatite B.» e' rimborsata come segue: Confezioni: 250 U.I./ml soluzione per infusione, 1 siringa di vetro da 2,4 ml A.I.C. n. 038445019 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex factory (IVA esclusa): €
196,20;
Prezzo al pubblico (IVA inclusa): €
323,81;
250 U.I./ml soluzione per infusione, 1 siringa di vetro da 4 ml AIC n. 038445021 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex factory (IVA esclusa): €
327,00;
Prezzo al pubblico (IVA inclusa): €
539,68;
250 U.I./ml soluzione per infusione, 1 flaconcino di vetro da 40 ml A.I.C. n. 038445045 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex...
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