COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Atossisclerol». (14A00301)
Estratto determinazione V &
A/4 del 7 gennaio 2014 Titolare AIC: Chemische Fabrik Kreussler &
CO. GMBH con sede legale e domicilio in Rheingaustrasse 87-93, D-65203 - Wiesbaden-Biebrich (Germania). Medicinale: ATOSSISCLEROL. Variazione AIC: 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;
A.7 Soppressione dei siti di fabbricazione anche per una sostanza attiva, un prodotto intermedio o finito, un sito di imballaggio, un fabbricante responsabile del rilascio dei lotti,un sito in cui si svolge il controllo dei lotti o un fornitore di materia prima;
B.II.b.2.a Modifica delle modalita' di liberazione dei lotti e delle prove di controllo qualitativo del prodotto finito. Sostituzione o aggiunta di un sito. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata e' autorizzata la modifica degli stampati. Gli stampati corretti ed approvati sono allegati alla presente determinazione. E' autorizzata l'eliminazione di 2 officine: Baxter Oncology GmbH - Kantstrasse 2- Halle/Westfalia (Germania) (fase di produzione soluzione e confezionamento primario;
Lomapharm Rudolf Lohmann GmbH KG - Langes Feld 5 - Emmerthal...
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