COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Emerade» (17A02101)
Estratto determina AAM/PPA n.249 del 3 marzo 2017 Autorizzazione della variazione: C.I.13). Relativamente al medicinale: EMERADE. Numero procedura europea: n. SE/H/1261/001-003/II/011. Titolare A.I.C.: Pharmaswiss Ceska Republika S.R.O. E' autorizzata la seguente variazione: sottomissione del protocollo di uno studio PK/PD (nell'ambito di un aggiornamento del RMP)relativamente al medicinale «Emerade», ed 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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