COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Nibestan» (18A01141)
Estratto determina PPA n. 73/2018 del 26 gennaio 2018 B.I.a.1.b) Introduzione di un fabbricante del principio attivo avente il sostegno di un Active Substance Master File (ASMF) relativamente alla specialita' medicinale NIBESTAN ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: UK/H/1904/001/II/011. Titolare A.I.C.: Farma Group S.r.l. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta ai sensi dell'art. 1 comma 5...
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