COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Quetiapina AHCL». (16A03310)
Estratto determina V&A/600 del 30 marzo 2016 Autorizzazione della variazione: C.I.11.b) Relativamente al medicinale: QUETIAPINA AHCL Numero Procedura Europea: UK/H/3525/001-005/II/010 Titolare AIC: Accord Healthcare Limited E' autorizzata la seguente variazione: Introduzione di una nuova versione del Risk Management Plan per Quetiapina (versione 2 DLP 10 luglio 2015) relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Smaltimento scorte I lotti gia' prodotti possono essere...
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