COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Brimonidina Ratiopharm». (12A04507)
Estratto Determinazione V & A/391 del 23 marzo 2012
Specialita' Medicinale: BRIMONIDINA RATIOPHARM
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento.
Titolare AIC: RATIOPHARM GMBH
N° Procedura Mutuo Riconoscimento: DK/H/1270/001/II/010
Tipo di Modifica: Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzato nel procedimento di fabbricazione di una sostanza attiva o modifica del fabbricante della sostanza attiva.
Modifica Apportata: AGGIORNAMENTO DEL DRUG MASTER FILE DA PARTE DEL PRODUTTORE...
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