COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Tiorfix». (17A06373)
Estratto determina AAM/PPA n. 836 del 31 luglio 2017 Autorizzazione della variazione: B.I.z modifiche qualitative del principio attivo - Altra variazione. Relativamente al medicinale: TIORFIX. Numero procedura europea: SE/H/1342/001-003/II/041. Titolare A.I.C.: Bioprojet Europe LTD. E' autorizzata la seguente variazione: aggiornamento ASMF dell'API «Racecadotril» relativo al produttore di API gia' autorizzato «Synkem» relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Smaltimento scorte I lotti gia'...
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