COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Curoxim». (16A01483)
Estratto determina V&A n. 252/2016 del 4 febbraio 2016 Sono autorizzate le seguenti variazioni: C.I.4) Modifica dei paragrafi 4.2 e 5.1 del riassunto delle caratteristiche del prodotto, modifiche minori al paragrafo 4.8 e adeguamento al QRD template e corrispondenti sezioni del foglio illustrativo relativamente al medicinale"CUROXIM", nelle seguenti forme e confezioni: 023576010 - "250 mg/ml polvere e solvente per sospensione iniettabile per uso intramuscolare" 1 flaconcino polvere + 1 fiala solvente 1 ml;
023576022 - "500 mg/2 ml polvere e solvente per sospensione iniettabile per uso intramuscolare" 1 flacone 500 mg + 1 fiala solvente 2 ml;
023576034 - "750 mg/3 ml polvere e solvente per sospensione iniettabile per uso intramuscolare" 1 flaconcino polvere + 1 fiala solvente 3 ml;
023576046 - "1 g/4 ml polvere e solvente per sospensione iniettabile per uso intramuscolare" 1 flacone 1 g + 1 fiala solvente 4 ml;
023576059 - "1 g/10 ml polvere e solvente per soluzione iniettabile per uso endovenoso" 1 flacone 1 g + 1 fiala solvente 10 ml;
023576061 - "2 g polvere per soluzione per infusione " 1 flacone 2 g;
023576085 - "750 mg polvere per soluzione per infusione " 1 flacone da 750 mg con dispositivo monovial;
023576097 - "1,5 g polvere per soluzione per infusione " 1 flaconcino da 1,5 g con dispositivo monovial. Procedure : NO/H/xxxx/ws/004 e IT/H/0347/001-008/II/02. Titolare AIC: Glaxosmithkline S.p.a. 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...
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