COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Mabelio» (19A02423)
Estratto determina AAM/PPA n. 290/2019 del 2 aprile 2019 L'autorizzazione all'immissione in commercio e' rinnovata con validita' illimitata dalla data del rinnovo europeo 20 ottobre 2018 con conseguente modifica degli stampati;
vengono modificati i paragrafi 1,7,9 delle etichette esterne e tutti i paragrafi delle etichette interne;
si aggiungono i paragrafi 17 e 18 delle etichette esterne;
le etichette vengono adeguate al QRD template relativamente al medicinale MABELIO. Confezioni: «500 mg polvere per concentrato per soluzione per infusione» 10 flaconcini in vetro da 20 ml. Titolare A.I.C.: Correvio, con sede legale e domicilio fiscale in Rue de Bicentenaire, 15 (92800 Puteaux). Procedura rinnovo. Codice procedura europea: UK/H/5304/001/R/001. Codice pratica: FVRMC/2018/12. Stampati L'etichettatura relativa al medicinale di cui all'art. 1 deve essere conforme a quanto allegato alla presente determina. Le modifiche di cui al comma 1 devono essere apportate per l'etichettatura entro e non oltre sei mesi dalla medesima data. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modifiche ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano...
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