PFIZER ITALIA S.R.L. - Modifiche secondarie di un'AIC di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i.
Modifiche secondarie di un'AIC di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i. Ai sensi della Determinazione AIFA 25 agosto 2011 si informa dell'avvenuta approvazione delle seguenti modifiche apportate in accordo al regolamento (CE) 1234/2008: Specialita' medicinale: MISOFENAC 75 Confezioni e numeri di AIC: "75mg+200mcg compresse a rilascio modificato" 10 compresse AIC n. 029316054/M "75mg+200mcg compresse a rilascio modificato" 30 compresse AIC n. 029316041/M Titolare: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice pratica: N1A/2013/48 Variazione B.II.a.1.a - Tipo IAin - Aggiunta impressioni sulle compresse: SEARLE sopra 1421 su un lato e 4 lettere A intorno alla circonferenza con 75 al centro, sull'altro lato Specialita' medicinale: DAUNOBLASTINA Confezioni e numero di AIC: 20mg/10ml polvere e solvente per soluzione iniettabile AIC n. 021035023 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice Pratica: N1A/2013/84 Variazione di Tipo IA n. A.4 - Modifica del nome del produttore del principio attivo: da Antibioticos S.p.A a Olon S.p.A. Specialita' medicinale: OLBETAM Confezioni e numero AIC: "250mg capsule" 30 capsule AIC n. 025307024 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice Pratica: N1A/2013/83 Variazione di Tipo IA n. A.4 - Modifica del nome del produttore del principio attivo: da Antibioticos S.p.A a Olon S.p.A. Specialita' medicinale: Omeprazolo Pfizer AIC n. 041384(tutte le confezioni)/M n. MRP: MT/H/0121/001-003/IA/004 Ramipril AIC n. 040680(tutte le confezioni)/M n. MRP: MT/H/107/001-002/IA/008 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice Pratica: C1A/2012/2969 Grouping di variazioni...
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