COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Clexane» (13A08163)
Estratto determinazione V &
A/1597 del 27 settembre 2013 Titolare AIC: Sanofi-Aventis S.p.a. (codice fiscale 00832400154) con sede legale e domicilio fiscale in Viale Luigi Bodio, 37/B - 20158 Milano (MI) Italia. Medicinale: CLEXANE. 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 (Punto 4.8 del RCP) e corrispondente paragrafo del foglio illustrativo, relativamente...
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