COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Acido Ibandronico Sandoz» (14A09456)
Estratto determina V &
A n. 2472/2014 del 20 novembre 2014 Procedura EU n.: UK/H/3375/001/II/014. E' autorizzata la seguente variazione: introduzione del nuovo produttore di sostanza attiva Ibandronato sodico monoidrato: Pharmaceutical Works Polpharma S.A. 19, Pelplinska Str., 83-200 Starogard Gdanski, Polonia, in possesso di ASMF (MFD-37006-2-16650-0001), Version 04, sia per l'Applicant's Part che per la Restricted Part e dell'aggiornamento MFD-25124-2-15165-0002 del 27 giugno 2013, relativamente al medicinale: ACIDO IBANDRONICO SANDOZ ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare...
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