COMUNICATO - Modificazione all''autorizzazione all''immissione in commercio del medicinale «Equilid» (10A05726)
Estratto determinazione AIC/N/V n. 991 del 29 aprile 2010
Titolare A.I.C.: Bruno Farmaceutici S.p.A. (codice fiscale n. 05038691001) con sede legale e domicilio fiscale in via delle Ande n. 15 - 00144 Roma, Italia.
Medicinale: EQUILID.
Variazione A.I.C.: modifica stampati su richiesta amministrazione.
E' autorizzata la modifica degli stampati (punti 4.4 e 4.8 del RCP e corrispondenti paragrafi del foglio illustrativo, inserimento avvertenze per la guida in etichetta).
Relativamente alla confezione sottoelencata:
A.I.C. n. 022572061 - «200 mg compresse» 20 compresse.
I lotti gia' prodotti non possono piu' essere dispensati al...
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