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: LISINOPRIL MERCK GENERICS.
Confezioni e numeri di A.I.C.:
per tutte le conf. autorizzate di "5 mg e 20 mg compresse" in flacone e blister (Comunicato AIFA del 28 novembre 2007).
Codice pratica: C1A/2007/2425 Procedura n. DK/H/0154/001,003/IA/036.
Modifica n. 8.b.2 Aggiunta del sito McDermott Laboratories Ltd t/a Gerard laboratories 35736 Baldoyle Industrial Estate grande Road Dublin 13 Ireland.
Specialita' medicinale: SOTALOLO MERCK GENERICS.
Confezioni e numeri di A.I.C.:
per tutte le conf. autorizzate di "80 mg compresse" in flacone e blister (Comunicato AIFA del 28 novembre 2007).
Codice pratica: C1A/2007/2413 procedura n. DK/H/0103/001-002/IA/020.
Modifica n. 8.b.1 Aggiunta del seguente sito per il rilascio lotti (escluso il controlli dei lotti): Pharma-pack kft, 2040 Budaors, Vasut u 13, Hungary.
Specialita' medicinale: LORAZEPAM MERCK GENERICS.
Confezioni e numeri di A.I.C.:
per tutte le confezioni autorizzate.
Pratica n. N1B/07/2163 dell'11 gennaio 2007.
Modifica n. 13b e consequenziale 12.a: Sostituzione di una procedura di prova e conseguente restringimento delle specifiche.
Specialita' medicinale: ACYCLOSTAD.
(Provv. UPC/I/20/2008 del 9 gennaio 2008). Codice pratica: C1B/2007/1060.
Procedura n. NL/H/0151/001/IB/009.
Modifica n. 2. Mod. del nome del prodotto medicinale. A seguito di trasf. di titolarita' dell'A.I.C. da Union Health S.r.l. a Merck...
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