Austedo (deutetrabenazine)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- deutetrabenazine
- Company
- Teva GmbH
- Status
- Authorised
- Therapeutic area
- Tardive Dyskinesia
- CHMP opinion
- Wed 05 Nov 2025
- EU approval
- Thu 08 Jan 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006371
- ATC
- N07XX16
- Official record
- www.ema.europa.eu
Indication
Treatment of moderate to severe tardive dyskinesia in adults.
Regulatory milestones
Thu 08 Jan 2026🇪🇺 EU approval (EC decision)
Austedo (deutetrabenazine) approved in the EU
Marketing authorisation to Teva GmbH; Additional monitoring · source
Wed 05 Nov 2025🇪🇺 CHMP positive opinion
Austedo (deutetrabenazine): CHMP positive opinion
Follow Austedo
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.