SANDOZ S.P.A. -
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007 n.274 e del Regolamento (CE) 1234/2008 Titolare: Sandoz S.p.A. Medicinale: TAMSULOSINA SANDOZ 0,4 mg capsule rigide a rilascio modificato. Confezioni: Tutte - Codice AIC Medicinale: 037010/M Procedura Europea n° FI/H/0497/001/IA/027/G Codice Pratica: C1A/2012/2716 Grouping variation parzialmente approvata: Modifica Tipo IA n. A.7 - Eliminazione del sito di produzione del bulk, controllo, confezionamento primario e secondario: Actavis Ltd, Malta. Medicinale: SIMVASTATINA SANDOZ 10 mg, 20 mg e 40 mg compresse rivestite con film. Confezioni: Tutte - Codice AIC Medicinale: 037206/M Procedura Europea n° DE/H/2045/002-003;005/IA/027 Codice Pratica: C1A/2013/761 Modifica Tipo IAin n. B.III.1.a.1 - Presentazione nuovo CEP per il principio attivo da parte del produttore gia' autorizzato Biocon Limited: da DMF version 2009/08 a CEP n. R0-CEP 2012-337-Rev 00. Medicinale: FLUDARABINA SANDOZ 25 mg/ml concentrato per soluzione iniettabile o per infusione. Confezioni: Tutte - Codice AIC Medicinale: 038746/M Procedura Europea n° DE/H/0801/001/IA/011/G Codice Pratica: C1A/2013/0185 Grouping variation: n. 3 tipo IA n. B.III.1.a.2 - Aggiornamento CEP per il principio attivo da parte dei produttori gia' autorizzati Sicor Srl da R0-CEP 2005-257-Rev 01 a R1-CEP 2005-257-Rev 00 e Zhejiang Hisun Pharmaceutical Co., Ltd da R0-CEP 2006-076-Rev 00 a R0-CEP 2006-076-Rev 01 + tipo IAin n. B.III.1.a.1 - Presentazione nuovo CEP per il principio attivo da parte del produttore gia' autorizzato Euticals SpA (e relativo aggiornamento nome) da DMF 01/2004 a R0-CEP 2009-282-Rev 00. Medicinale: BRIMONIDINA SANDOZ 2 mg/ml collirio, soluzione. Confezioni: Tutte - Codice AIC Medicinale: 039016/M Procedura Europea n° DK/H/1267/001/IA/014 Codice Pratica: C1A/2013/574 Modifica Tipo IAin n. B.II.b.1.a - Aggiunta sito per il confezionamento secondario: Pieffe Depositi Srl, Via Formellese Km 4,300, 00060 Formello (Roma), Italia. Medicinale: METFORMINA GLIBENCLAMIDE SANDOZ 500 mg/2,5 mg e 500 mg/5 mg compresse rivestite con film. Confezioni: Tutte - Codice AIC Medicinale: 039719/M Procedura Europea n° NL/H/1544/001-002/IA/002 Codice Pratica: C1A/2013/489 Modifica Tipo IA n. B.III.1.a.2 - Aggiornamento CEP per il principio attivo metformina...
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