COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Differin» (17A01799)
Estratto determina AAM/PPA n. 154 del 17 febbraio 2017 Autorizzazione delle variazioni: Variazione di tipo II: C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, e le Variazioni di tipo II: B.I.z) Altre variazioni, relativamente al medicinale DIFFERIN. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alla sezione 4.2 e corrispondente paragrafo del foglio illustrativo;
sono inoltre autorizzati gli aggiornamenti degli ASMF come di seguito indicati: per il produttore Helsinn: da ASMF versione 2010 a ASMF sequenza 0012;
per il produttore Finorga: da ASMF versione 2010 a ASMF versione 3.2 del gennaio 2012, relativamente al medicinale «Differin», nelle forme e confezioni sottoelencate: A.I.C. n. 029309034 - «0,1% gel» tubo 30 g;
A.I.C. n. 029309046 - «0,1% crema» tubo da 30 g. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Galderma Italia S.P.A. (codice fiscale 01539990349) con sede legale e domicilio fiscale in Via Dell'Annunciata, 21, 20121 - Milano (MI) Italia. Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determinazione al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo. 2. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni e integrazioni, il foglio...
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