Is Tipiracil + Trifluridine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Tipiracil + Trifluridine, including LONSURF (15,6.14 mg,mg, Film-coated tablet, SAR 1944.90); LONSURF (20,8.19 mg,mg, Film-coated tablet, SAR 2511.10); Trumavar (15,6.14 mg,mg, Film-coated tablet, SAR 1815.25); Trumavar (20,8.19 mg,mg, Film-coated tablet, SAR 2343.70).

Is Tipiracil + Trifluridine approved by the US FDA?

Drugs@FDA lists 3 application product lines for Tipiracil + Trifluridine, including LONSURF (Prescription); TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (Prescription); TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (Prescription).

Is Tipiracil + Trifluridine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tipiracil + Trifluridine: Lonsurf.

Active substances

Tipiracil + Trifluridine

SFDA 4
US FDA 3
EMA 1
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LONSURF	15,6.14 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 1944.90	NCE · Prescription	LES LABORATORIES SERVIER	Valid
LONSURF	20,8.19 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 2511.10	NCE · Prescription	LES LABORATORIES SERVIER	Valid
Trumavar	15,6.14 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 1815.25	Generic · Prescription	Boston Oncology Arabia	Valid
Trumavar	20,8.19 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 2343.70	Generic · Prescription	Boston Oncology Arabia	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LONSURF	EQ 6.14MG BASE;15MG; EQ 8.19MG BASE;20MG	tablet · oral	TAIHO ONCOLOGY	Prescription	22 Sep 2015
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	EQ 6.14MG BASE;15MG; EQ 8.19MG BASE;20MG	tablet · oral	NATCO	Prescription	13 Jun 2023
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	EQ 6.14MG BASE;15MG; EQ 8.19MG BASE;20MG	tablet · oral	MSN	Prescription	8 Jan 2025

EMA European Union — centrally authorised medicines

Lonsurf Les Laboratoires Servier · Authorised · authorised 25 Apr 2016 · ATC L01BC59

Therapeutic indication (EMA)

Colorectal cancer Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agents Gastric cancer Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LONSURF	02472104	15 MG; 6.14 MG	TABLET · ORAL	TAIHO PHARMA CANADA, INC.
LONSURF	02472112	20 MG; 8.19 MG	TABLET · ORAL	TAIHO PHARMA CANADA, INC.

Components

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), 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.