COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Azitromicina Teva Italia» (18A04699)
Estratto determina AAM/PPA n. 608 del 26 giugno 2018 Autorizzazione delle variazioni: Variazione di tipo II: 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, e la Variazione di tipo IA, relativamente al medicinale AZITROMICINA TEVA ITALIA;
Numeri di procedura: n. NL/H/0945/001/II/033 n. NL/H/0945/001/IA/034 E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alle sezioni 2, 3, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 6.4 e 6.6 e corrispondenti paragrafi del foglio illustrativo, e l'aggiornamento delle etichette, modifiche editoriali ed adeguamento al QRD template, relativamente al medicinale «Azitromicina Teva Italia», nelle forme e confezioni sotto elencate: 038929016 - «200 mg/5 ml polvere per sospensione orale» 1 flacone da 15 ml 038929028 - «200 mg/5 ml polvere per sospensione orale» 1 flacone da 22,5 ml 038929030 - «200 mg/5 ml polvere per sospensione orale» 1 flacone da 30 ml 038929042 - «200 mg/5 ml polvere per sospensione orale» 1 flacone da 37,5 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Teva Italia S.R.L., con sede legale e domicilio fiscale in Milano (MI), Piazzale Luigi Cadorna, 4, CAP 20123, Italia, codice fiscale 11654150157 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 al foglio illustrativo e all'etichettatura. 2. In...
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