COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Montelukast Gedeon Richter». (15A04083)
Estratto determina V&A n. 881/2015 del 13 maggio 2015 Procedura EU n.: HU/H/0186/003/II/008/G Variazione di tipo II: B.III.2.b) B.II.d.1.d) B.II.d.1.e) Sono autorizzate la seguenti variazioni: I requisiti per l'uniformita' di massa della compressa nelle specifiche al rilascio e al termine del periodo di validita' del prodotto finito sono state aggiornate secondo la versione in vigore della Ph. Eur, monografia 2.9.5.;
Il limite per l'impurezza C (sulfossido) e' stato modificato nelle specifiche alla shelf-life da 0.5% a 1.0% ed il limite per la somma delle impurezze e' stato ampliato al termine del periodo di validita' da 1.7% a 2.0%. Sono autorizzate le ulteriori modifiche aggiuntive: modifica dei simboli dei metodi dovuto al nuovo sistema di marcatura in Gedeon Richter Polska Sp. z.o.o.;
modifica del nome delle impurezze secondo la corrente monografia della Ph. Eur. Su...
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