COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Morfina Cloridrato Monico», con conseguente modifica degli stampati. (19A02881)
Estratto determina AAM/PPA n. 325/2019 del 15 aprile 2019 L'autorizzazione all'immissione in commercio del medicinale: MORFINA CLORIDRATO MONICO;
confezioni A.I.C. n.: 030798 019 - «10 mg/ ml soluzione iniettabile» 5 fiale 1 ml;
030798 021 - «20 mg/ml soluzione iniettabile» 5 fiale 1 ml;
030798 033 - «10 mg/ml soluzione iniettabile» 1 fiala 1 ml;
030798 045 - «20 mg/ ml soluzione iniettabile» 1 fiala 1 ml;
030798 058 - «50 mg/5 ml soluzione iniettabile» 5 fiale 5 ml;
030798 060 - «100 mg/10 ml soluzione iniettabile» 5 fiale 10 ml;
030798 072 - «100 mg/5 ml soluzione iniettabile» 5 fiala 5 ml;
030798 084 - «200 mg/10 ml soluzione iniettabile» 5 fiale 10 ml;
titolare A.I.C.: Monico S.p.a.;
procedura: nazionale;
codice pratica: FVR/2008/460 - N1B/2018/550 - N1A/2018/1560, con scadenza il 16 dicembre 2008 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura ed a condizione che, alla data di entrata in vigore della presente determina, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Sono inoltre autorizzate la variazione N1A/2018/1560, concernente laraccomandazione del CMDh di giugno 2018 «Morphine, morphine-cyclizine: CMDh scientific conclusion and ground for variation, amendements to the product information and timetable for the implementation - PSUSA/00010549/201710» e la variazione N1B/2018/550 concernente la raccomandazione del CMDh di febbraio 2018 «Concomitant use of benzodiazepines/benzodiazepine like products and opioids». Le modifiche devono essere apportate immediatamente per il riassunto delle caratteristiche del prodotto mentre per il foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determina. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24...
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