COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Bosentan Accord». (17A04011)
Estratto determina AAM/PPA n. 560 del 30 maggio 2017 Autorizzazione della variazione: B.II.d.1 z) Modifica dei parametri di specifica e/o dei limiti del prodotto finito - Altra variaizone, B.I.a.1.b) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla Farmacopea europea Relativamente al medicinale: BOSENTAN ACCORD. Numero procedura europea: UK/H/5622/001-002/II/002/G. Titolare AIC: Accord Healthcare Limited. E' autorizzata la seguente variazione: B.I.a.1.b: Introduzione del fabbricante Urquima S.A. (Urquima S.A Arnau de Vilanova 22-42, 08105 Sant Fost de Campsentelles Barcelona-Spain) per il principio attivo Bosentan monoidrato, avente il sostegno di un ASMF (AP / Version 03 / 2016-01);
B.II.d.1.Z: Modifica dei parametri di specifica e/o dei limiti del prodotto finito. Altre variazioni. Modifiche delle specifiche al rilascio e alla shelf life. ===================================================================== | DA | A | +==============================+====================================+ | Ogni singola impurezza: NMT | Idrossisulfonamide: NMT 0.20% | | 0.20% Impurezze Totali: NMT |...
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