MERCK GENERICS ITALIA - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di un medicinale per uso umano. (Modifiche apportate ai sensi del
regolamento (CE) n. 1084/2003 - legge 24 dicembre 2003 n. 350).
Specialita' medicinale: TERAZOSINA MERCK GENERICS.
Confezioni e numeri A.I.C.:
per tutte le confezioni autorizzate- A.I.C. n. 036148/M .
Provvedimento UPC/I/6404/2007 del 13 luglio 2007. UK/H/572/02-03/IA/01, var. tipo IA n. 5: modifica del nome del produttore assemblatore e QC site del prodotto finito: da Egis Pharmaceuticals Ltd a Egis Pharmaceuticals PLC.
Provvedimento UPC/I/6403/2007 del 13 luglio 2007, UK/H/572/02-03/IA/03, var. tipo IA n. 9: eliminazione del seguente sito: Generics (UK) Ltd, Unit 2-5, Amor Way, Letchworth, SG5 1UG, United Kingdom.
Specialita' medicinale: RANITIDINA MERCK GENERICS.
Confezioni e numeri di A.I.C.:
per tutte le confezioni autorizzate - A.I.C. n. 035302/M.
Provvedimento UPC/I/6395/2007 del 13 luglio 2007 DK/H/101/01-02/IB/20: var tipo IB n. 42.a.1: modifica del periodo di validita' del prodotto finito come confezionato per la vendita da 3 anni a 4 anni.
Specialita' medicinale: BACAMPICILLINA MERCK GENERICS.
Confezioni e numeri di A.I.C.:
"1,2 g compresse rivestite con film" 12 compresse - A.I.C. n. 034297034.
Codice pratica N1A/07/1247, var. tipo IA n. 15.b.2: ulteriore produttore del principio attivo bacampicillina cloridrato, con presentazione di un certificato di idoneita' alla Farmacopea Europea, R0-CEP 2002-216-Rev...
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