Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 12 March 2018
Indication(s)
Aripiprazole Sandoz 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 Sandoz 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.
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More information
Category | Value |
---|---|
Agency product number | EMEA/H/C/004008 |
Orphan designation | No |
Date First Approved | 20-08-2015 |
Type | Medicinal product subject to medical prescription |
Marketing authorisation holder | Sandoz GmbH |