Sycrest (asenapine)
- Region
- 🇪🇺 EU
- Active substance
- asenapine
- Company
- Organon N.V.
- Status
- Authorised
- Therapeutic area
- Bipolar Disorder
- CHMP opinion
- Thu 24 Jun 2010
- EU approval
- Wed 01 Sep 2010
- Application
- EMEA/H/C/001177
- ATC
- N05AH05
- Official record
- www.ema.europa.eu
Indication
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.