COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Imukin». (12A04073)
Estratto determinazione V & A/322 del 12 marzo 2012
Specialita' Medicinale: IMUKIN.
Confezioni: 028138016/M - 6 Flaconi 0,5 ML 100 MCG
Titolare AIC: Boehringer Ingelheim Italia S.P.A.
Numero Procedura Mutuo Riconoscimento: NL/H/0033/001/II/025 - NL/H/0033/001/W15 - NL/H/0033/001/R/03 - NL/H/0033/001/IA/29 - NL/H/0033/001/IB/32.
Tipo di Modifica: Modifica stampati.
Modifica Apportata: e' autorizzata la modifica degli stampati alle sezioni: 4.1 - 4.2 - 4.4 - 4.5 - 4.6 - 4.7 - 4.8 e 5.1 del Riassunto delle Caratteristiche del Prodotto, dei corrispondenti paragrafi del Foglio Illustrativo e delle Etichette. Ulteriori modifiche apportate a seguito della procedura di rinnovo europeo. E' autorizzata, altresi', la modifica del Foglio Illustrativo a seguito dei risultati del «Readability User Test». Gli stampati corretti ed approvati sono allegati alla presente determinazione.
Modifica del nome del produttore del prodotto medicinale finito da: Boehringer Ingelheim Austria GmbH a Boehringer Ingelheim RCV GmbH & Co KG.
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...
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