Regulatory PathRegulatory requirements compared

Active substances

Gimeracil + Oteracil + Tegafur

Open in the medicines table

EMA European Union — centrally authorised medicines

Teysuno Nordic Group B.V. · Authorised · authorised 14 Mar 2011 · ATC L01BC53

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
TEYSUNO 15 MG/4.35 MG/11.8 MG HARD CAPSULESPL 40621/0037NORDIC GROUP BVPOM
TEYSUNO 20 MG/5.8 MG/15.8 MG HARD CAPSULESPL 40621/0038NORDIC GROUP BVPOM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.