This is a summary of the European public assessment report (EPAR) for Aripiprazole Zentiva. 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 Zentiva. For practical information about using Aripiprazole Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva 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 Zentiva 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.
Therapeutic Area (MeSH)
ATC Code
N05AX12
ATC Item
aripiprazole
Pharmacotherapeutic Group
Psycholeptics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| aripiprazole | N/A | 阿立哌唑 |
EMA Name
Aripiprazole Zentiva
Medicine Name
Aripiprazole Zentiva
Aliases
N/ANo risk management plan link.
