COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vasokinox». (15A05054)
Estratto determina V&A n. 1171/2015 del 17 giugno 2015 Autorizzazione della variazione: C.I.6.a) relativamente al medicinale: VASOKINOX. Numero di procedura: BE/H/0134/001/II/016 Modifica del Riassunto delle Caratteristiche del Prodotto ai paragrafi 4.1-4.5;
4.8, 5.1, 6.4, 6.5, 6.6, 7, 8. e corrispondenti paragrafi del Foglio Illustrativo 1-6 allo scopo di aggiungere l'estensione dell'indicazione terapeutica al trattamento, unitamente a supporto ventilatorio e ad altri principi attivi idonei, di neonati e bambini ≥
34 settimane di gestazione con insufficienza respiratoria ipossica associata a evidenza clinica o ecocardiografica di ipertensione polmonare, al fine di migliorare l'ossigenazione e ridurre la necessita' di circolazione con membrana extracorporea (ECMO). Modifica delle etichette in accordo al QRD Template Nella forma e confezioni sottoelencate: 038474019 - "450 ppm mole/mole, gas medicinale, compresso bombola al da 5l 038474021 - "450 ppm mole/mole, gas medicinale, compresso bombola al da 20l Gli stampati corretti ed approvati sono allegati alla presente determinazione. Titolare AIC: Air Liquide Sante (International) (SIS 3031) 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 dell'uso complementare di lingue estere, deve darne preventiva comunicazione all'AIFA e tenere a disposizione la traduzione giurata dei testi in lingua tedesca e/o in...
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