COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Orelox» (18A01652)
Estratto determina AAM/PPA n. 150 del 19 febbraio 2018 Autorizzazione delle variazioni: variazione di tipo II: C.I.4 Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza, e variazione di tipo IB: C.I.z) Altre variazioni (aggiornamento foglio illustrativo in seguito ai risultati del Readability User test e adeguamento dell'RCP e delle etichette al QRD template), relativamente al medicinale ORELOX. Codici pratica: VN2/2017/230 N1B/2015/4131 E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alla sezioni 2, 4.2, 4.3, 4.4, 4.6 (solo titolo), 4.7, 4.8, 4.9, 5.1, 6.6 (solo per la formulazione bambini granulato per sospensione orale) e dell'intero foglio illustrativo ed etichette, relativamente al medicinale «Orelox», nelle forme e confezioni sottoelencate: A.I.C. n. 027970019 - «100 mg compresse rivestite con film»12 compresse» A.I.C. n. 027970021 - «Bambini granulato per sospensione orale» flacone da 50 ml A.I.C. n. 027970033 - «Bambini granulato per sospensione orale» 1 flacone 100 ml A.I.C. n. 027970045 - «200 mg compresse rivestite con film» 6 compresse Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare A.I.C.: Sanofi S.p.A. (codice fiscale 00832400154) con sede legale e domicilio fiscale in viale Luigi Bodio, 37/B - 20158 Milano, Italia. 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...
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