Winthrop Pharmaceuticals Italia - S.r.l.
MODIFICHE SECONDARIE DI UN'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO DI UN MEDICINALE PER USO UMANO. MODIFICHE APPORTATE AI SENSI DEL DECRETO LEGISLATIVO 29 DICEMBRE 2007, N. 274
TITOLARE: Winthrop Pharmaceuticals Italia S.r.l., viale L. Bodio n.
37/b, Milano.
Medicinale: VENLAFAXINA WINTHROP 37,5 mg - 75 mg e 150 mg capsule rigide a rilascio prolungato Confezioni: tutte Numero A.I.C.: 037881/M Procedura n. NL/H/933/01-02-03/IA/012 - Tipo IA n. 7b1 e conseguente Tipo IA n.7a: Aggiunta di Sanofi-Aventis Sp. z. o.o.,
Drug Production and Distribution Plant, ul. Lubelska 52, 35-233
Rzeszow Polonia come sito responsabile del confezionamento primario, secondario del prodotto finito.
Procedura n. NL/H/933/01-02-03/IA/013 - Tipo IA n.8b2: Aggiunta di Sanofi-Aventis Sp. z. o.o., Drug Production and Distribution Plant, ul. Lubelska 52, 35-233 Rzeszow Polonia come sito responsabile rilascio lotti, incluso il controllo, del prodotto finito.
Medicinale: VENLAFAXINA WINTHROP 75 mg e 150 mg capsule rigide a rilascio prolungato Confezioni: tutte Numero A.I.C.: 037881/M Procedura n. NL/H/933/02-03/IA/014 - Tipo IA n.41a1: modifica del numero di unita' in una confezione entro l'intervallo di dimensioni attualmente autorizzato (aggiunta della confezione da 49 capsule per il dosaggio da 75 mg e 150 mg).
Medicinale: VENLAFAXINA WINTHROP 150 mg capsule rigide a rilascio prolungato Confezioni: tutte Numero A.I.C.: 037881/M Procedura n. NL/H/933/03/IA/015 - Tipo IA n.41a1: modifica del numero di unita' in una...
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