COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sandimmun Neoral». (15A05975)
Estratto determina V&A/1322 del 14 luglio 2015 Autorizzazione della variazione: B.V.b.1.b) Relativamente al medicinale: SANDIMMUN NEORAL Numero procedura Europea: DE/H/4019/001-005/II/006 Titolare AIC: Novartis Europharm LTD E' autorizzata la seguente variazione: Armonizzazione di tutto il Modulo 3 (formato CTD) in seguito a conclusione di referral da art. 30, incluse le seguenti modifiche: Modifiche nei parametri di specifica e relativi limiti di un eccipiente (mono/di/trigliceridi da olio di semi di mais) Presentazione di certificati di conformita' alla farmacopea europea per un eccipiente (gelatina): nuovo (R1-CEP 2002-021-Rev 02) e aggiornato (R1-CEP 2000-117-Rev 01) Sono inoltre modificati i seguenti siti produttivi (si riportano i soli siti oggetto di modifica): 100 mg/ml soluzione orale Parte di provvedimento in formato grafico Eliminazione del seguente sito di rilascio dei lotti: Famar France 1, Avenue du Champ de Mars, 45072 Orleans Cedex 02, France Commitment: La ditta dovra' presentare una variazione per l'eliminazione del sito di rilascio dei lotti della formulazione capsule molli (10mg, 25mg, 50mg, 100mg) "Novartis International Pharmaceuticals Limited, Ireland" entro 3 mesi dalla conclusione delle procedure europee in...
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