EG 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
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: EG S.p.A Specialita' Medicinale: ZOPICLONE EG Numeri A.I.C. e Confezioni: 034398 - In tutte le confezioni. Cod. Pratica: C1A/2012/3039 - Proc. Europea n° NL/H/0163/001/IA/062 Modifica Tipo IAin n. B.II.b.1.a - Confezionamento secondario anche presso De Salute Srl. Specialita' Medicinale: MIRTAZAPINA EG Numeri A.I.C. e Confezioni: 036555 - In tutte le confezioni. Cod. Pratica: C1A/2013/123 - Proc. Europea n° DE/H/3354/001-003/IA/004 Modifica Tipo IAin n. B.III.1.a.3 - Presentazione nuovo CEP (R0-CEP 2008-214-Rev 00) del nuovo produttore del principio attivo Megafine PHARMA (P) Limited, India. Specialita' Medicinale: SERTRALINA EG Numeri A.I.C. e Confezioni: 036597 - In tutte le confezioni. Codice Pratica: C1B/2013/116 - Procedura Europea n° DE/H/0422/001-002/IB/023 Modifica Tipo IBfo n. B.I.d.1.a.4 - Introduzione del re-test period del principio attivo di 60 mesi per il produttore Wanbury Limited. Specialita' Medicinale: QUINAPRIL IDROCLOROTIAZIDE EG Numeri A.I.C. e Confezioni: 037228 - In tutte le confezioni. Cod. Pratica: C1A/2013/0323 - Proc. Europea n° SE/H/0442/002/IA/023 Modifica Tipo IA n. B.III.1.a.2 - Aggiornamento CEP del produttore Teva Pharm. Ind. Ltd per il principio attivo Idroclorotiazide: da R1-CEP 2004-149-Rev 00 a R1-CEP 2004-149-Rev 01. Specialita' Medicinale: ACIDO VALPROICO E SODIO VALPROATO EG Numeri A.I.C. e Confezioni: 038036- In tutte le confezioni. Procedura Europea n° DE/H/0811/001-002/IA/010/G Grouping variation: n. 2 x Tipo IA n. B.III.1.a.2 - Aggiornamenti CEP del produttore autorizzato Katwijk Chemie BV per il principio attivo Acido Valproico da R1-CEP 1998-026-Rev 01 a R1-CEP 1998-026-Rev 02 e per il principio attivo Sodio Valproato da R1-CEP 1997-021-Rev 01 a R1-CEP 1997-021-Rev 03. Specialita' Medicinale: PRAMIPEXOLO EG Numeri A.I.C. e Confezioni: 039188 - In tutte le confezioni. Codice Pratica: C1A/2013/224 - Procedura Europea n° DE/H/1110/002;004/IA/016/G Grouping variation: Tipo IAin n. B.II.b.2.b.1 -...
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