COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Braunol». (13A07765)
Estratto determinazione V &
A 1445 del 9 settembre 2013 Titolare AIC: B. BRAUN MELSUNGEN AG con sede legale e domicilio in CARL BRAUN STRASSE, 1 - 34212 - MELSUNGEN (GERMANIA) Medicinale: BRAUNOL Variazione AIC: B.II.c.1.a Modifica dei parametri di specifica e/o dei limiti di un eccipiente - Rafforzamento dei limiti delle specifiche B.II.c.1.b Modifica dei parametri di specifica e/o dei limiti di un eccipiente Aggiunta di un nuovo parametro di specifica alla specifica e con il suo metodo di prova corrispondente B.II.c.1.c Modifica dei parametri di specifica e/o dei limiti di un eccipiente Soppressione di un parametro di specifica non significativo B.II.c.1.d Modifica dei parametri di specifica e/o dei limiti di un eccipiente Modifica al di fuori dei limiti di specifiche approvati L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: Sono autorizzate le modifiche di seguito riportate: 1 Tipo IA B.II.c.1 Modifica dei parametri di specifica e/o dei limiti di un eccipiente a) rafforzamento dei limiti delle specifiche. 3 Tipo IA B.II.c.1 Modifica dei parametri di specifica e/o dei limiti di un eccipiente b) aggiunta di un nuovo parametro di specifica alla specifica e con il suo metodo di prova corrispondente 1 Tipo IA B.II.c.1 Modifica dei parametri di specifica e/o dei limiti di un eccipiente c) soppressione di un parametro di specifica non significativo (per esempio soppressione di un...
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