COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Pramipexolo Aurobindo». (13A07767)
Estratto determinazione V &
A n. 1472 del 10 settembre 2013 Specialita' medicinale: PRAMIPEXOLO AUROBINDO Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Titolare AIC: AUROBINDO PHARMA (ITALIA) S.R.L. N. Procedura Mutuo Riconoscimento: PT/H/0660/002,004/II/002 Tipo di Modifica: C.I z) Altra variazione Modifica apportata: Introduzione del nuovo Risk Management Plan per Pramipexolo Aurobindo (compresse) conforme al Regolamento (EU)1235/2010 e Direttiva...
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