COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Purinethol» (12A02530)
Estratto determinazione V & A/ 173 del 16 febbraio 2012
Titolare AIC: Laboratoires Genopharm S.A.S. con sede legale e domicilio in 10, Rue Enrico Fermi - 77462 Saint Thibault Des Vignes - Lagny Sur Marne - Cedex (Francia)
Medicinale: PURINETHOL
Variazione AIC: Modifica Stampati su Richiesta Ditta
E' autorizzata la modifica degli stampati (Punti 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1 e 5.2 del RCP e corrispondenti Paragrafi del Foglio illustrativo relativamente alla confezione sottoelencata:
AIC N. 010344012 - "50 mg compresse" 25 compresse
I lotti gia' prodotti non possono piu' essere dispensati al...
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