Tepezza (teprotumumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- teprotumumab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Graves Ophthalmopathy
- CHMP opinion
- Fri 25 Apr 2025
- EU approval
- Thu 19 Jun 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006396
- ATC
- L04AG13
- Official record
- www.ema.europa.eu
Indication
Treatment of moderate to severe thyroid eye disease (TED).
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.