COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Diaxone» (10A04395)
Estratto determinazione UVA/N/V n. 776 del 22 marzo 2010
Titolare A.I.C.: Euro-Pharma S.r.l. (codice fiscale n. 06328630014) con sede legale e domicilio fiscale in corso Tassoni, 25 - 10143 Torino (Italia).
Medicinale: DIAXONE.
Variazione A.I.C.: modifica stampati su richiesta amministrazione.
E' autorizzata la modifica degli stampati (punti 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.2 e 6.2 e corrispondenti paragrafi del foglio illustrativo; inserimento nella etichetta esterna della frase «L'assunzione del medicinale puo' alterare la capacita' di guidare veicoli e di usare macchinari». Non miscelare con soluzioni contenenti calcio, incluse soluzioni di Hartmann, Ringer e soluzioni parenterali totali»; ed in etichetta interna (flaconcino polvere) della frase: «Non miscelate con soluzioni contenenti calcio».
Il foglio illustrativo ed il riassunto delle caratteristiche del prodotto corretti ed...
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