Aripiprazole - EPARs for authorised medicinal products for human use - Abilify

FICHA FARMACOLÓGICA de Aripiprazole Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. DICIEMBRE 22, 2009.

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EPARs for authorised medicinal products for human use - Abilify

Active Substance
Aripiprazole
International Nonproprietary Name or Common Name
Aripiprazole
Pharmaco-therapeutic Group
Other antipsychotics
ATC Code
N05 AX12

Therapeutic Indication:
Tablets, orodispersible tablets and oral solution:

ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.
ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment .

Solution for injection:
ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate.

Treatment with aripiprazole solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated

Date of issue of Marketing Authorisation valid throughout the European Union
4 June 2004

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use