COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Methotrexate». (15A06806)
Estratto determina V&A n. 1473 del 27 luglio 2015 Autorizzazione della variazione: C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, relativamente al medicinale METHOTREXATE;
E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto e del foglio illustrativo, relativamente al medicinale METHOTREXATE, nelle forme e confezioni sottoelencate: AIC n. 019888015 - "2,5 mg compresse" 25 compresse AIC n. 019888027 - "2,5 mg compresse" 100 compresse AIC n. 019888039 - "5 mg polvere per soluzione iniettabile" 1 flacone AIC n. 019888041 - "50 mg polvere per soluzione iniettabile" 1 flacone AIC n. 019888054 - "500 mg polvere per soluzione iniettabile" 1 flacone AIC n. 019888066 - "1 g/10 ml soluzione iniettabile" 1 flacone da 10 ml AIC n. 019888078 - "5 g/50 ml soluzione iniettabile" 1 flacone da 50 ml AIC n. 019888080 - "50 mg/2 ml soluzione iniettabile" 1 flacone da 2 ml AIC n. 019888092 - "500 mg/20 ml soluzione iniettabile" 1 flacone da 20 ml AIC n. 019888104 - "1 g polvere per soluzione iniettabile" 1 flacone AIC n. 019888116 - "7,5 mg/ml soluzione iniettabile" 4 siringhe preriempite da 1 ml AIC n. 019888128 - "10 mg/1,33 ml soluzione iniettabile" 4 siringhe preriempite 1,33 ml AIC n. 019888130 - "15 mg/2 ml soluzione iniettabile" 4 siringhe preriempite da 2 ml AIC n. 019888142 - "20 mg/2,66 ml soluzione iniettabile" 4 siringhe preriempite da 2,66 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: PFIZER ITALIA S.R.L. (codice fiscale 06954380157) con sede legale e domicilio fiscale in Via Isonzo, 71, 04100 - Latina (LT) Italia Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di...
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