Is Cabozantinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Cabozantinib, including CABOMETYX 20 mg F.C. Tablet (20 mg, Film-coated tablet, SAR 14744.00); CABOMETYX 40 mg F.C. Tablet (40 mg, Film-coated tablet, SAR 14744.00); CABOMETYX 60 mg F.C. Tablet (60 mg, Film-coated tablet, SAR 14744.00); Cabozantinib BOS (20 mg, Tablet, SAR 13761.05); Cabozantinib BOS (40 mg, Film-coated tablet, SAR 13761.05).

Is Cabozantinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Cabozantinib, including CABOZANTINIB (Prescription); RESNIBEN (Prescription).

Is Cabozantinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cabozantinib: Cometriq.

Are there safety signals or safety updates for Cabozantinib?

EMA PRAC: 4 entries (latest 2022-05-05).

Active substance

Cabozantinib

SFDA 6
US FDA 2
EMA 1
Health Canada 3
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CABOMETYX 20 mg F.C. Tablet	20 mg	Film-coated tablet · Oral use	30 Bottle	SAR 14744.00	NCE · Prescription	IPSEN PHARMA	Valid
CABOMETYX 40 mg F.C. Tablet	40 mg	Film-coated tablet · Oral use	30 Bottle	SAR 14744.00	NCE · Prescription	IPSEN PHARMA	Valid
CABOMETYX 60 mg F.C. Tablet	60 mg	Film-coated tablet · Oral use	30 Bottle	SAR 14744.00	NCE · Prescription	IPSEN PHARMA	Valid
Cabozantinib BOS	20 mg	Tablet · Oral use	30 Bottle	SAR 13761.05	Generic · Prescription	Boston Oncology Arabia	Valid
Cabozantinib BOS	40 mg	Film-coated tablet · Oral use	30 Bottle	SAR 13761.05	Generic · Prescription	Boston Oncology Arabia	Valid
Cabozantinib BOS	60 mg	Tablet · Oral use	30 Bottle	SAR 13761.05	Generic · Prescription	Boston Oncology Arabia	Valid

Indications — CHI Daman Drug Formulary

HEPATOCELLULAR CARCINOMA; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; THYROID CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
CABOZANTINIB	20MG; 40MG; 60MG	tablet · oral	TEVA PHARMS INC	Prescription
RESNIBEN	13MG; 26MG; 39MG	tablet · oral	AZURITY	Prescription

EMA European Union — centrally authorised medicines

Cometriq Ipsen Pharma · Authorised · authorised 21 Mar 2014 · ATC L01XE

Therapeutic indication (EMA)

Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CABOMETYX	02480824	20 MG	TABLET · ORAL	IPSEN BIOPHARMACEUTICALS CANADA INC
CABOMETYX	02480832	40 MG	TABLET · ORAL	IPSEN BIOPHARMACEUTICALS CANADA INC
CABOMETYX	02480840	60 MG	TABLET · ORAL	IPSEN BIOPHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 5 May 2022 PRAC signal: Tumour lysis syndrome
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 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No

All safety entries for cabozantinib →

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.