Teysuno (tegafur;gimeracil;oteracil)
- Region
- 🇪🇺 EU
- Active substance
- tegafur;gimeracil;oteracil
- Company
- Nordic Group B.V.
- Status
- Authorised
- Therapeutic area
- Stomach Neoplasms
- EU approval
- Mon 14 Mar 2011
- Application
- EMEA/H/C/001242
- ATC
- L01BC53
- Official record
- www.ema.europa.eu
Indication
Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.
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.