COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Nicardal». (13A07727)
Estratto determinazione V &
A/1428 del 9 settembre 2013 Titolare AIC: ITALFARMACO S.P.A. (codice fiscale 00737420158) con sede legale e domicilio fiscale in VIALE FULVIO TESTI, 330, 20126 - MILANO (MI) Italia Medicinale: NICARDAL 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 ecliniche 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. 025991011 - "20 mg compresse rivestite" 30 compresse AIC...
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