Modificazione dell'autorizzazione all'immissione in commercio della specialita' medicinale per uso umano
Estratto determinazione A.I.C./N/V n. 955 del 22 dicembre 2005
Medicinale: RISPERDAL.
Titolare A.I.C.: Janssen Cilag S.p.a., con sede legale e domicilio fiscale in via Michelangelo Buonarroti, 23 - 20093 Cologno Monzese - Milano - Italia, codice fiscale n. 00962280590.
Variazione A.I.C.: aggiunta/modifica (esclusa eliminazione) delle indicazioni terapeutiche.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata:
Si autorizza la ´Modifica delle indicazioni terapeutiche - Le indicazioni terapeutiche ora autorizzate sono le seguenti: "Risperdal e' indicato nel trattamento delle psicosi schizofreniche acute e croniche. Risperdal inoltre migliora i sintomi affettivi (come p.e. depressione, senso di colpa, ansia) associati alla schizofrenia.
Risperdal e' indicato nel trattamento dell'episodio di mania nel disturbo bipolare".ª.
Relativamente alle confezioni sottoelencate:
A.I.C. n. 028752018 - ´1 mg compresse rivestite con filmª 20 compresse;
A.I.C. n. 028752020 - ´2 mg compresse rivestite con filmª 20 compresse;
A.I.C. n. 028752032 - ´3 mg compresse rivestite con filmª 20 compresse;
A.I.C. n. 028752044 - ´4 mg compresse rivestite con filmª 20 compresse;
A.I.C. n. 028752057 - ´1 mg compresse rivestite con filmª 60...
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