Basic Information
Aripiprazole Accord
Regulatory Information
EMEA/H/C/004021
November 15, 2015
September 23, 2015
16
July 13, 2022
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord 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 adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Aripiprazole Accord. For practical information about using Aripiprazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.