COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Dantrium» (19A02132)
Estratto determina AAM/PPA n. 216 del 12 marzo 2019 Si autorizza il seguente grouping di variazioni: Tipo II, C.I.11b), introduzione del Risk Management Plan, versione n. 3.2.;
Tipo IB, B.IV.1z), aggiunta di un nuovo dispositivo di filtrazione monouso per tutte le confezioni. Si modificano i paragrafi 4.2, 4.4, 6.5 e 6.6 del riassunto delle caratteristiche del prodotto e dei corrispondenti paragrafi del foglio illustrativo e delle etichette, con adeguamento dei testi al QRD template, versione corrente. Le suddette variazioni si applicano alla specialita' medicinale DANTRIUM, nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia, a seguito di procedura nazionale: Confezioni e numeri di A.I.C.: 024372082 - «20 mg polvere per soluzione per infusione» 36 flaconcini;
024372094 - «20 mg polvere per soluzione per infusione» 12 flaconcini. Gli stampati corretti ed approvati sono allegati alla presente determina. Numero procedura: UK/H/XXXX/WS/0267. Titolare A.I.C.: Norgine Italia S.r.l. (codice fiscale 11116290153). 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...
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