COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Deca Durabolin». (13A09016)
Estratto determinazione V &
A/1836 del 30 ottobre 2013 Titolare AIC: N.V. Organon con sede legale e domicilio in Kloosterstraat, 6, 5349 AB - OSS Paesi Bassi (Olanda). Medicinale: DECA DURABOLIN. 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 alla confezione sottoelencata: AIC N. 017712011 - «25 mg/1...
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