🇪🇺 Deutetrabenazine Oral Capsule in European Union

EMA authorised Deutetrabenazine Oral Capsule on 8 January 2026

Marketing authorisation

EMA — authorised 8 January 2026

  • Application: EMEA/H/C/006371
  • Marketing authorisation holder: Teva GmbH
  • Local brand name: Austedo
  • Indication: Treatment of moderate to severe tardive dyskinesia in adults.
  • Status: approved

The European Medicines Agency (EMA) approved Austedo (Deutetrabenazine Oral Capsule) for the treatment of moderate to severe tardive dyskinesia in adults. This approval was granted to Teva GmbH, the marketing authorisation holder. Austedo is a medication that has been shown to reduce the symptoms of tardive dyskinesia, a condition characterised by involuntary movements of the face, trunk, and limbs.

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Deutetrabenazine Oral Capsule in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Deutetrabenazine Oral Capsule approved in European Union?

Yes. EMA authorised it on 8 January 2026.

Who is the marketing authorisation holder for Deutetrabenazine Oral Capsule in European Union?

Teva GmbH holds the EU marketing authorisation.