COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Momendol» (20A01816)
Estratto determina AAM/PPA n. 194 del 10 marzo 2020 Autorizzazione delle variazioni: Variazione di tipo II: C.I.z), e le variazioni di tipo IB: C.I.z e C.I.3.z), relativamente al medicinale MOMENDOL;
Codici pratica: VN2/2019/253 N1B/2015/2809 N1B/2018/1293 E' autorizzato la modifica delle sezioni 2, 4.4, 4.5 e 10 del riassunto delle caratteristiche del prodotto, e corrispondenti paragrafi del foglio illustrativo, e delle etichette relativamente al medicinale Momendol nelle forme e confezioni: A.I.C. n. 025829122 - «220 mg granulato per soluzione orale» 12 bustine E' autorizzato la modifica delle sezioni 2, 3, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.2, 6.6 e 10 del riassunto delle caratteristiche del prodotto, e corrispondenti paragrafi del foglio illustrativo, e delle etichette relativamente al medicinale Momendol nelle forme e confezioni: A.I.C. n. 025829211 - «220 mg capsula molle» 10 capsule in blister PVC/PCTFE/AL;
A.I.C. n. 025829223 - «220 mg capsula molle» 12 capsule in blister PVC/PCTFE/AL;
A.I.C. n. 025829235 - «220 mg capsula molle» 20 capsule in blister PVC/PCTFE/AL;
A.I.C. n. 025829247 - «220 mg capsula molle» 24 capsule in blister PVC/PCTFE/AL;
A.I.C. n. 025829250 - «220 mg capsula molle» 30 capsule in blister PVC/PCTFE/AL. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Titolare A.I.C.: Aziende chimiche riunite Angelini Francesco ACRAF S.p.a. (codice fiscale n. 03907010585) con sede legale e domicilio fiscale in viale Amelia n. 70 - 00181 - Roma (RM) Italia Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina 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...
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