DETERMINA 24 settembre 2014 - Rettifica e corrigendum delle indicazioni alla determina UAE n. 794 del 24 luglio 2014 delle confezioni autorizzate del medicinale per uso umano «Aubagio». (Determina n. 1011/2014). (14A07810)
IL DIRETTORE GENERALE Vista la determina dell'Ufficio assessment europeo n. 794 del 24 luglio 2013 riguardante, tra le altre, la autorizzazione all'immissione in commercio del medicinale AUBAGIO codice di AIC 042921015/E - 042921027/E - 042921039/E - 042921041/E - 042921054/E pubblicata nella Gazzetta Ufficiale serie generale n. 200 del 29 agosto 2014;
Vista la determina n. 837 dell'Ufficio prezzi e rimborso del 31 luglio 2014 pubblicata nella Gazzetta Ufficiale n.187 del 13 agosto 2014 con la quale e' stato autorizzato il regime di rimborsabilita' ed il prezzo alle seguenti confezioni del medicinale AUBAGIO: EU/1/13/838/002 14 mg - compressa rivestita con film - uso orale - blister (ALU/ALU) - 28 compresse AIC: 042921027. EU/1/13/838/003 14 mg - compressa rivestita con film - uso orale - blister (ALU/ALU) - 84 compresse AIC: 042921039. Considerato che, per errore materiale contenuto negli allegati alla determinazione ed in particolare nelle indicazioni e delle confezioni autorizzate del medicinale AUBAGIO, occorre provvedere alla rettifica della determinazione suddetta dell'Ufficio assessment europeo;
Visti gli atti d'ufficio: Determina: (Rettifica corrigendum delle indicazioni alla determina UAE n. 794 del 24 luglio 2014 delle confezioni autorizzate del medicinale AUBAGIO) Laddove e' riportato: Indicazioni terapeutiche AUBAGIO e' indicato per il trattamento di pazienti adulti affetti da sclerosi multipla recidivante ricorrente (SM). Leggasi: Indicazioni terapeutiche AUBAGIO e' indicato per il trattamento di pazienti adulti affetti da sclerosi multipla recidivante remittente (SM). (Rettifica degli...
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