COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Omeprazolo Germed Pharma». (14A03085)
Estratto determinazione V &
A/640 del 26 marzo 2014 Specialita' Medicinale: OMEPRAZOLO GERMED PHARMA. Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Titolare AIC: GERMED PHARMA S.p.a. N° Procedura Mutuo Riconoscimento: IT/H/0379/001/II/002. Tipo di modifica: B.II.b.4.d Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito La modifica riguarda tutte le altre forme farmaceutiche fabbricate secondo procedimenti di fabbricazione complessi Modifica Apportata: Modifica della dimensione del...
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