COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Niflam». (13A07783)
Estratto determinazione V &
A/1521 del 16 settembre 2013 Titolare AIC: Bristol-Myers Squibb S.A.R.L. con sede legale e domicilio in 3 Rue Joseph Monier 92500 - Rueil Malmaison (Francia). Medicinale: NIFLAM Variazione AIC: C.I.4 Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica degli stampati relativamente alle confezioni sottoelencate: AIC n. 022824015 - «250 mg capsule rigide» 30 capsule AIC n...
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