COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Vastarel» (11A05303)
Estratto determinazione V & A.N/V n. 471 del 14 marzo 2011
Titolare AIC: Ist. Farm. Biol. Stroder S.r.l. (codice fiscale 00394900484) con sede legale e domicilio fiscale in via di Ripoli, 207 V - 50126 Firenze Italia.
Medicinale: VASTAREL.
Variazione AIC: modifica stampati su richiesta amministrazione.
E' autorizzata la modifica degli stampati (punto 4.4 e 4.8 del RCP e corrispondente paragrafo del foglio illustrativo e delle etichette), relativamente alla confezione sottoelencata:
AIC n. 027511029 - «20 mg compresse rivestite» 60 compresse.
I lotti gia' prodotti non possono piu' essere dispensati al...
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