🇪🇺 TEPEZZA in European Union

EMA authorised TEPEZZA on 19 June 2025

Marketing authorisation

EMA — authorised 19 June 2025

  • Application: EMEA/H/C/006396
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Tepezza
  • Indication: Treatment of moderate to severe thyroid eye disease (TED).
  • Status: approved

The EMA approved TEPEZZA (teprotumumab) for the treatment of moderate to severe thyroid eye disease (TED). This approval was granted to Amgen Europe B.V. on 19 June 2025. TEPEZZA is a monoclonal antibody that targets the IGF-1 receptor, which is involved in the development of TED.

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TEPEZZA 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 TEPEZZA approved in European Union?

Yes. EMA authorised it on 19 June 2025.

Who is the marketing authorisation holder for TEPEZZA in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.