Teduglutide Viatris (teduglutide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- teduglutide
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Short Bowel Syndrome
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Thu 08 Jan 2026
- Designations
- Generic
- Application
- EMEA/H/C/006564
- ATC
- A16AX08
- Official record
- www.ema.europa.eu
Indication
Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.
Regulatory milestones
Thu 08 Jan 2026🇪🇺 EU approval (EC decision)
Teduglutide Viatris (teduglutide) approved in the EU
Marketing authorisation to Viatris Limited; Generic · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Teduglutide Viatris (teduglutide): CHMP positive opinion
Viatris Limited; Generic · source
Same substance in other markets
- 🇪🇺 Revestive Authorised · Takeda Pharmaceuticals International AG Ireland
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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.