COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Omeprazolo Sandoz GMBH». (13A08124)
Estratto determinazione V &
A n._1533 del 17 settembre 2013 Specialita' medicinale: OMEPRAZOLO SANDOZ GMBH Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Titolare AIC: SANDOZ GMBH N. Procedura Mutuo Riconoscimento: UK/H/1024/001-002/11/029/G Tipo di Modifica: B.II.a.3.b.5 TIPO II Modifiche nella composizione (eccipienti) del prodotto finito Altri eccipienti Modifica sostenuta da uno studio sulla bioequivalenza B.II.b.3.b TIPO II Modifica nel procedimento di fabbricazione del prodotto finito Modifiche importanti nel procedimento di fabbricazione, suscettibili di avere un impatto significativo sulla qualita', la sicurezza o l'efficacia del medicinale B.II.b.4.a TIPO IA* Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito Sino a 10 volte superiore alla dimensione attuale approvata del lotto B.II.b.5.e TIPO II Modifica delle prove in corso di fabbricazione o dei limiti applicati durante la fabbricazione del prodotto finito Allargamento dei limiti IPC approvati, suscettibile di avere un effetto significativo sulla qualita' globale del prodotto finito B.II.d.1.e TIPO II Modifica dei parametri di specifica e/o dei limiti del prodotto finito Modifica al di fuori dei limiti di specifica approvati B.II.d.2.d TIPO IB Modifica della procedura di prova del prodotto finito Altre modifiche di una procedura di prova B.II.e.1.a.1 TIPO IA Modifica dell'imballaggio primario del prodotto finito Composizione qualitativa e quantitativa forme farmaceutiche solide Modifica apportata: Modifica della composizione degli eccipienti: contenuto delle capsule: Idrossipropil-cellulosa a bassa sostituzione Cellulosa Microcristallina Lattosio anidro Povidone K25 Polisorbato 80 Talco Magnesio ossido Acido metacrilico co-polimero, 30% dispersione acquosa di tipo C Trietil citrato Magnesio stearato Involucro delle capsule: Da: capsule di ipromellosa, A...
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