COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Steozol», con conseguente modifica stampati. (17A08758)
Estratto determina AAM/PPA n. 1130/2017 del 27 novembre 2017 Medicinale: STEOZOL Confezioni: 040982 011 - «4 mg/5 ml concentrato per soluzione per infusione» 1 siringa in plastica da 5 ml con ago per ricostituzione 040982 023 - «4 mg/5 ml concentrato per soluzione per infusione» 3 siringhe in plastica da 5 ml con 3 aghi per ricostituzione 040982 035 - «4 mg/5 ml concentrato per soluzione per infusione» 4 siringhe in plastica da 5 ml con 4 aghi per ricostituzione 040982 047 - «4 mg/5 ml concentrato per soluzione per infusione» 10 siringhe in plastica da 5 ml con 10 aghi per ricostituzione Titolare AIC: Italfarmaco S.p.a. Procedura Decentrata IT/H/0269/001/R/001 con scadenza il 23 maggio 2017 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del riassunto delle caratteristiche del prodotto e del foglio illustrativo ed a condizione che, alla data di entrata in vigore della presente determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Le modifiche devono essere apportate immediatamente per il riassunto delle caratteristiche del prodotto mentre per il foglio illustrativo entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modifiche e integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia...
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