COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Candesartan e Idroclorotiazide Actavis». (14A03074)
Estratto determinazione V &
A/599 del 18 marzo 2014 Specialita' medicinale: CANDESARTAN E IDROCLOROTIAZIDE ACTAVIS. Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Titolare AIC: Actavis Group PTC EHF. Numero procedura mutuo riconoscimento: DK/H/1839/001-002/II/007. Tipo di modifica: B.I.a z) Modifica del processo di produzione del principio attivo. Altra variazione. Modifica apportata: aggiornamento dell'ASMF del produttore di principio attivo Candesartan cilexetil Rambaxy Laboratories Limited...
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