COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Rivotril». (13A09898)
Estratto determinazione V &
A/2074 del 22 novembre 2013 Titolare AIC: Roche S.P.A. (codice fiscale 00747170157) con sede legale e domicilio fiscale in Piazza Durante, 11 - 20131 - Milano - Italia. Medicinale: RIVOTRIL. 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 (Punti 4.8 del RCP e corrispondenti Paragrafi del Foglio Illustrativo e delle etichette), relativamente alle...
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