Is Regorafenib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Regorafenib, including STIVARGA 40 mg film-coated tablet (40 mg, Film-coated tablet, SAR 11620.10).

Is Regorafenib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Regorafenib, including STIVARGA (Prescription); STIVARGA (Prescription); REGORAFENIB (Discontinued).

Is Regorafenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Regorafenib: Stivarga.

Are there safety signals or safety updates for Regorafenib?

EMA PRAC: 13 entries; US FDA: 1 entry (latest 2026-02-03).

Active substance

Regorafenib

SFDA 1
US FDA 3
EMA 1
Health Canada 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
STIVARGA 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	84 Tablet Container	SAR 11620.10	NCE · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

BONE SARCOMAS; BRAIN CANCERS; COLORECTAL CANCER-ADVANCED/ METASTATIC; HEPATOCELLULAR CARCINOMA; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
STIVARGA	40MG	tablet · oral	BAYER HLTHCARE	Prescription	27 Sep 2012
STIVARGA	40MG	tablet · oral	BAYER HEALTHCARE PHARMS	Prescription	25 Feb 2013
REGORAFENIB	40MG	tablet · oral	ACTAVIS LABS FL	Discontinued	13 Jan 2025

EMA European Union — centrally authorised medicines

Stivarga Bayer Pharma AG · Authorised · authorised 26 Aug 2013 · ATC L01EX05

Therapeutic indication (EMA)

Stivarga 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 - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
STIVARGA	02403390	40 MG	TABLET · ORAL	BAYER INC

Safety signals and safety-related labeling changes

US FDA 3 Feb 2026 STIVARGA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2025 PRAC signal: Hyperammonaemia, hyperammonaemic encephalopathy
Action for MAH: update of the product information: Yes
EMA PRAC 10 Apr 2025 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No
EMA PRAC 13 Feb 2025 PRAC signal: Hyperammonaemia, hyperammonaemic encephalopathy
Action for MAH: update of the product information: No
EMA PRAC 28 Nov 2024 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2023 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2022 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2016 PRAC signal: Angioedema
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Angioedema
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Acute pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Haemolysis
Action for MAH: update of the product information: No
EMA PRAC 6 Mar 2014 PRAC signal: Hypersensitivity, drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No

All safety entries for regorafenib →

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.