Tibsovo (ivosidenib)
- Region
- 🇪🇺 EU
- Active substance
- ivosidenib
- Company
- Agios Netherlands B.V.
- Status
- Application withdrawn
- Therapeutic area
- Leukemia, Myeloid, Acute
- Application
- EMEA/H/C/005056
- ATC
- L01XX62
- Official record
- www.ema.europa.eu
Indication
Treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) and locally advanced or metastatic cholangiocarcinoma
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tibsovo Authorised · Les Laboratoires Servier
- 🇪🇺 Tidhesco Application withdrawn · Les Laboratoires Servier
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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.