COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Octagam» (18A01187)
Estratto determina n. 187/2018 del 7 febbraio 2018 Medicinale: OCTAGAM. Titolare A.I.C.: Octapharma LTD. La nuova indicazione terapeutica del medicinale «Octagam»: Polineuropatia demielinizzante infiammatoria cronica (CIDP). Esistono solo esperienze limitate sull'uso delle immunoglobuline endovenose nei bambini con CIDP. e' rimborsata come segue: Confezioni: «50 mg/ml soluzione per infusione» 1 flacone in vetro da 50 ml - A.I.C. n. 035143015 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex factory (IVA esclusa): €
126,00;
Prezzo al pubblico (IVA inclusa): €
207,95;
50 mg/ml soluzione per infusione
1 flacone in vetro da 100 ml - A.I.C. n. 035143027 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex factory (IVA esclusa): €
252,00;
Prezzo al pubblico (IVA inclusa): €
415,90;
50 mg/ml soluzione per infusione
1 flacone in vetro da 200 ml - A.I.C. n. 035143039 (in base 10);
Classe di rimborsabilita': H;
Prezzo ex factory (IVA esclusa): €
504,00;
Prezzo al pubblico (IVA inclusa): €
831,80. Sconto obbligatorio alle strutture pubbliche sul prezzo ex factory come da condizioni negoziali. Ai fini delle prescrizioni a carico del Servizio sanitario nazionale i centri utilizzatori specificatamente individuati dalle regioni, dovranno compilare la scheda raccolta dati informatizzata di arruolamento che indica i pazienti eleggibili e la scheda di follow-up, applicando le condizioni negoziali secondo le indicazioni pubblicate sul sito dell'Agenzia, piattaforma web - all'indirizzo https://www.agenziafarmaco.gov.it/registri/ che costituiscono parte integrante della presente determinazione. Nelle more della piena attuazione del registro di monitoraggio web-based, le prescrizioni, relative unicamente alle indicazioni rimborsate dal Servizio sanitario nazionale attraverso la presente determinazione, dovranno essere effettuate in accordo ai criteri di eleggibilita' e appropriatezza prescrittiva riportati nella documentazione...
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