COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ferinject» (18A03340)
Estratto determina AAM/PPA n. 363/2018 del 10 aprile 2018 Autorizzazione delle variazioni. C.I.4) - Modifica dei paragrafi 4.2, 4.4, 4.6, 4.8, 5.1, 5.2 del riassunto delle caratteristiche del prodotto e relativi paragrafi del foglio illustrativo relativamente al medicinale FERINJECT, nelle forme e confezioni: 040251011 - «50 mg/ml soluzione iniettabile/per infusione» 1 flaconcino in vetro da 2 ml 040251023 - «50 mg/ml soluzione iniettabile/per infusione» 5 flaconcini in vetro da 2 ml 040251035 - «50 mg/ml soluzione iniettabile/per infusione» 1 flaconcino in vetro da 10 ml 040251047 - «50 mg/ml soluzione iniettabile/per infusione» 5 flaconcini in vetro da 10 ml 040251074 - «50 mg/ml soluzione iniettabile/per infusione» 1 flaconcino in vetro da 20 ml Gli stampati corretti ed approvati sono allegati alla determinazione di cui al presente estratto. Procedura: UK/H/0894/001/II/035/G Titolare AIC: Vifor France 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 e all'etichettatura. 2. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i., il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia di Bolzano, anche in lingua tedesca. Il titolare dell'AIC che intende avvalersi...
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