COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Granulokine» (18A03456)
Estratto determina AAM/PPA n. 404/2018 del 23 aprile 2018 Autorizzazione delle variazioni: Rinnovo autorizzazione e variazione tipo II (C.I.4). L'autorizzazione all'immissione in commercio e' rinnovata con validita' illimitata dalla data del rinnovo europeo 20 aprile 2013 con conseguente modifica del riassunto delle caratteristiche del prodotto e del foglio illustrativo (UK/H/0019/001,010-011/R/004). E' autorizzata, altresi', la variazione di tipo II C.I.4: Modifica dei paragrafi 4.4, 4.7 e 4.8 del riassunto delle caratteristiche del prodotto e dei corrispettivi paragrafi del foglio illustrativo a seguito dell'aggiornamento alla versione piu' recente del Company Core Data Sheet (CDS v13 a v15) UK/H/0019/001,010-011/II/130 relativamente al Medicinale: GRANULOKINE (027772) Confezioni: A.I.C. n. 027772033 - «30 MU (0,3 mg/ml) soluzione iniettabile» 1 flaconcino da 1 ml;
A.I.C. n. 027772045 - «48 MU (0,3 mg/ml) soluzione iniettabile» 1 flaconcino da 1,6 ml;
A.I.C. n. 027772096 - «30 MU (0,6 mg/ml) soluzione iniettabile in siringa preriempita» 1 siringa da 0,5 ml;
A.I.C. n. 027772108 - «30 MU (0,6 mg/ml) soluzione iniettabile in siringa preriempita» 5 siringhe da 0,5 ml;
A.I.C. n. 027772110 - «48 MU (0,96 mg/ml) soluzione iniettabile in siringa preriempita» 1 siringa da 0,5 ml;
A.I.C. n. 027772122 - «48 MU (0,96 mg/ml) soluzione iniettabile in siringa preriempita» 5 siringhe da 0,5 ml. Titolare A.I.C.: AMGEN Europe B.V., con sede legale e domicilio fiscale in Minervum 7061, 4817ZK, Breda - Paesi Bassi (NL) Codice procedura europea: UK/H/0019/001,010-011/R/004;
UK/H/0019/001,010-011/II/130. Codice pratica: FVRMC/2012/368;
VC2/2017/441. Le modifiche devono essere apportate per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determinazione mentre per il foglio illustrativo non oltre sei mesi dalla medesima data. In ottemperanza all'art. 80, commi 1...
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