Is Sorafenib 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 Sorafenib, including NEXAVAR 200 MG F-C TABLETS (200 mg, Film-coated tablet, SAR 6702.35); Osvalu (200 mg, Film-coated tablet, SAR 6362.10); Sorafenib BOS (200 mg, Film-coated tablet, SAR 5138.60); Sorastad (200 mg, Film-coated tablet, SAR 7889.30).

Is Sorafenib approved by the US FDA?

Drugs@FDA lists 7 application product lines for Sorafenib, including NEXAVAR (Prescription); SORAFENIB TOSYLATE (Prescription); SORAFENIB TOSYLATE (Prescription); SORAFENIB TOSYLATE (Prescription); SORAFENIB TOSYLATE (Prescription).

Is Sorafenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sorafenib: Nexavar.

Are there safety signals or safety updates for Sorafenib?

EMA PRAC: 9 entries; US FDA: 1 entry (latest 2022-02-10).

Active substance

Sorafenib

SFDA 4
US FDA 7
EMA 1
Health Canada 1
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NEXAVAR 200 MG F-C TABLETS	200 mg	Film-coated tablet · Oral use	60 Blister	SAR 6702.35	NCE · Prescription	BAYER PHARMA AG	Valid
Osvalu	200 mg	Film-coated tablet · Oral use	56 Blister	SAR 6362.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Sorafenib BOS	200 mg	Film-coated tablet · Oral use	60 Blister	SAR 5138.60	Generic · Prescription	Boston Oncology Arabia	Valid
Sorastad	200 mg	Film-coated tablet · Oral use	112 Blister	SAR 7889.30	Generic · Prescription	STADA ARZNEIMITTEL GmbH	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); BONE SARCOMAS; HEPATOCELLULAR CARCINOMA; OVARIAN CANCER; PARATHYROID CANCER; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; THYROID CANCER-PAPILLARY, FOLLICULAR, HURTHLE CELL CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
NEXAVAR	EQ 200MG BASE	tablet · oral	BAYER HLTHCARE	Prescription	1 Dec 2005
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	MYLAN	Prescription	10 Sep 2020
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	TEVA PHARMS USA INC	Prescription	12 Nov 2020
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	DR REDDYS	Prescription	7 Jun 2022
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	YABAO PHARM	Prescription	9 Nov 2022
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	TORRENT	Prescription	12 Apr 2023
SORAFENIB TOSYLATE	EQ 200MG BASE	tablet · oral	APOTEX	Discontinued	27 Jan 2025

EMA European Union — centrally authorised medicines

Nexavar Bayer AG · Authorised · authorised 19 Jul 2006 · ATC L01EX02

Therapeutic indication (EMA)

Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NEXAVAR	02284227	200 MG	TABLET · ORAL	BAYER INC

Safety signals and safety-related labeling changes

EMA PRAC 10 Feb 2022 PRAC signal: Tumour lysis syndrome (TLS)
Action for MAH: update of the product information: Yes
EMA PRAC 30 Sep 2021 PRAC signal: Tumour lysis syndrome (TLS)
Action for MAH: update of the product information: No
US FDA 9 Jul 2020 NEXAVAR — 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 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 11 Apr 2019 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2015 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2014 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No

All safety entries for sorafenib →

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.