COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Mirtazapina Aurobindo Pharma Italia». (14A05551)
Estratto determinazione V &
A n. 1266 del 24 giugno 2014 Specialita' medicinale: MIRTAZAPINA AUROBINDO PHARMA ITALIA. Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare A.I.C.: Aurobindo Pharma (Italia) S.r.l. Numero procedura mutuo riconoscimento: PT/H/0463/002/II/004 Tipo di modifica: C.I z) Altra variazione. Modifica apportata: introduzione di un nuovo risk management plan (versione 1.0 del...
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