Mylan - S.p.a. (ex Merck Generics Italia - S.p.a.)
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai
sensi del regolamento (CE) n. 1084/2003).
Specialita' medicinale: CARVEDILOLO MERCK GENERICS.
Confezioni e numeri di A.I.C.:
036453/M - Tutte le confezioni autorizzate.
(Provv. UPC/I/94/2008 del 6 febbraio 2008). Codice pratica: C1A/2008/100. Procedura n. SE/H/0349/001-004/IA/019.
Modifica n: 9. Eliminazione del seguente sito responsabile del rilascio dei lotti: Chanelle Medical Limited, Irlanda.
(Provv. UPC/I/93/2008 del 6 febbraio 2008). Codice pratica: C1A/2008/101. Procedura n. SE/H/0349/001-004/IA/018.
Modifica n: 9. Eliminazione del seguente sito responsabile del rilascio dei lotti: Merck KGAA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.
(Provv. UPC/I/96/2008 del 6 febbraio 2008). Codice pratica: C1A/2008/98. Procedura n. SE/H/0349/001-004/IA/017.
Modifica n: 9. Eliminazione del seguente sito responsabile del rilascio dei lotti: Generics (UK) Ltd, Units 2 5 Amor Way, Letchworth Herts, UK.
(Provv. UPC/I/97/2008 del 6 febbraio 2008). Codice pratica: C1A/2008/97. Procedura n. SE/H/0349/001-004/1A/016.
Modifica n: 9. Eliminazione del seguente sito: Arcana Arzneimittel GbmH Zimbagasse 5, 1147 Wien Austria.
(Provv. UPC/I/98/2008 del 6 febbraio 2008). Codice pratica: C1A/2008/99. Procedura n. SE/H/0349/001-004/IA/015.
Modifica n: 5. Mod. del nome e dell'indirizzo del prod. del medicinale finito: da Specifar Pharmaceuticals, 11 Venizelou st., 123 51 Athens, Greece a Specifar S.A., 1, 28 Octovriou str., ag. Varvara, Athens, 123 51 Greece.
Specialita' medicinale: PAROXETINA MERCK GENERICS.
Confezioni e numeri di A.I.C.:
035449 - Tutte le confezioni autorizzate.
(Provv. UPC/I/122/2008 del 13 febbraio 2008). Codice pratica: C1A/2008/102. Procedura n. DK/H/02449/001/IA/017.
Modifica n: 22.a Present. certif. idoneita' TSE della Farmac. eur. aggiorn., relativo all'eccipiente Acido Stearico da parte del fornitore approvato Ambrogio Pagani...
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