Revestive (teduglutide)
- Region
- 🇪🇺 EU
- Active substance
- teduglutide
- Company
- Takeda Pharmaceuticals International AG Ireland
- Status
- Authorised
- Therapeutic area
- Malabsorption Syndromes
- EU approval
- Thu 30 Aug 2012
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002345
- ATC
- A16AX08
- Official record
- www.ema.europa.eu
Indication
Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Teduglutide Viatris Authorised · Viatris Limited
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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.