COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Nalador» (11A03901)
Estratto determinazione V & A.N/V n. 461 del 7 marzo 2011
Titolare A.I.C.: Bayer S.p.A. (codice fiscale 05849130157) con sede legale e domicilio fiscale in viale Certosa, 130 - 20156 Milano (Italia).
Medicinale: NALADOR.
Variazione A.I.C.: modifica degli stampati.
E' autorizzata la modifica degli stampati (Punti 4.2 e 4.4 del RCP e corrispondenti paragrafi del foglio illustrativo) relativamente alla confezione sottoelencata: A.I.C. n. 025998030 - «0,5 mg polvere per soluzione iniettabile» 1 fiala.
I lotti gia' prodotti non possono piu' essere dispensati al pubblico a decorrere...
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