SANDOZ S.p.A.
Modifiche secondarie di un'autorizzazione all'immissione in
commercio di specialita' medicinale per uso umano
Titolare: Sandoz S.p.A., Largo U. Boccioni, 1 - 21040 Origgio (VA)
Medicinale: TAMSULOSINA Sandoz.
Codice AIC Medicinale: 037010/M
Modifiche apportate ai sensi del Regolamento (CE) 1084/2003:
Provvedimento UPC/I/5558/2007
Procedura Europea nr. FI/H/0497/01/IB/08
Modifica tipo I n. 42 a1 - Estensione del periodo di validita' del prodotto finito come confezionato per la vendita: da 30 mesi a 36 mesi.
Provvedimento UPC/I/5620/2007
Procedura Europea nr. FI/H/0497/01/IA/09
Modifica tipo I n. 8 b2 - Aggiunta sito per il rilascio lotti, incluso il controllo lotti: Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben Germania.
I lotti gia'...
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