Is Sunitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 21 valid registrations of Sunitinib, including REMOSTA (50 mg, Capsule, hard, SAR 12446.00); REMOSTA (25 mg, Capsule, hard, SAR 6223.00); REMOSTA (12.5 mg, Capsule, hard, SAR 3111.50); RENIS 12.5 MG CAPSULE (12.5 mg, Capsule, hard, SAR 3919.35); RENIS 25 MG CAPSULE (25 mg, Capsule, hard, SAR 7838.70).

Is Sunitinib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Sunitinib: Sutent, Sunitinib Accord.

Are there safety signals or safety updates for Sunitinib?

EMA PRAC: 6 entries (latest 2019-07-11).

Active substance

Sunitinib

SFDA 21
EMA 2
Health Canada 18
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
REMOSTA	50 mg	Capsule, hard · Oral use	30 Blister	SAR 12446.00	Generic · Prescription	SPIMACO	Valid
REMOSTA	25 mg	Capsule, hard · Oral use	30 Blister	SAR 6223.00	Generic · Prescription	SPIMACO	Valid
REMOSTA	12.5 mg	Capsule, hard · Oral use	30 Blister	SAR 3111.50	Generic · Prescription	SPIMACO	Valid
RENIS 12.5 MG CAPSULE	12.5 mg	Capsule, hard · Oral use	30 Blister	SAR 3919.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
RENIS 25 MG CAPSULE	25 mg	Capsule, hard · Oral use	30 Blister	SAR 7838.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
RENIS 50MG CAPSULE	50 mg	Capsule, hard · Oral use	30 Blister	SAR 15677.45	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Renulib	12.5 mg	Capsule, hard · Oral use	30 Blister	SAR 908.60	Generic · Prescription	HEXAL	Valid
Renulib	25 mg	Capsule, hard · Oral use	30 Blister	SAR 1817.20	Generic · Prescription	HEXAL	Valid
Renulib	50 mg	Capsule, hard · Oral use	30 Blister	SAR 3634.45	Generic · Prescription	HEXAL	Valid
SUTENT 12.5 MG CAPSULE	12.5 mg	Capsule, hard · Oral use	30 Tablet Container	SAR 4124.90	NCE · Prescription	PFIZER	Valid
SUTENT 25 MG CAPSULE	25 mg	Capsule, hard · Oral use	30 Tablet Container	SAR 8029.25	NCE · Prescription	PFIZER	Valid
SUTENT 50 MG CAPSULE	50 mg	Capsule, hard · Oral use	30 Tablet Container	SAR 15707.95	NCE · Prescription	PFIZER	Valid
SUTEXA 12.5MG CAPSULE	12.5 mg	Capsule, hard · Oral use	30 Blister	SAR 3527.40	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SUTEXA 25MG CAPSULE	25 mg	Capsule, hard · Oral use	30 Blister	SAR 7054.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SUTEXA 50MG CAPSULE	50 mg	Capsule, hard · Oral use	30 Blister	SAR 14109.70	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Sunitinib Pharmacare	12.5 mg	Capsule, hard · Oral use	30 Bottle	SAR 3111.50	Generic · Prescription	Pharmacare Premium Ltd	Valid
Sunitinib Pharmacare	25 mg	Capsule, hard · Oral use	30 Bottle	SAR 6223.00	Generic · Prescription	Pharmacare Premium Ltd	Valid
Sunitinib Pharmacare	50 mg	Capsule, hard · Oral use	30 Bottle	SAR 11739.80	Generic · Prescription	Pharmacare Premium Ltd	Valid
Sutixib	50 mg	Capsule, hard · Oral use	30 Bottle	SAR 12446.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Sutixib	25 mg	Capsule, hard · Oral use	30 Bottle	SAR 6223.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Sutixib	12.5 mg	Capsule, hard · Oral use	30 Bottle	SAR 3111.50	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid

Indications — CHI Daman Drug Formulary

BRAIN CANCERS; NEUROENDOCRINE TUMORS; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; THYROID CANCER-PAPILLARY, FOLLICULAR, HURTHLE CELL CARCINOMA

EMA European Union — centrally authorised medicines

Sutent Pfizer Limited · Authorised · authorised 19 Jul 2006 · ATC L01EX01

Therapeutic indication (EMA)

Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1).

Sunitinib Accord Accord Healthcare S.L.U. · Authorised · authorised 11 Feb 2021 · ATC L01EX01

Therapeutic indication (EMA)

Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-SUNITINIB	02532190	12.5 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-SUNITINIB	02532204	25 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-SUNITINIB	02532220	50 MG	CAPSULE · ORAL	AURO PHARMA INC
NAT-SUNITINIB	02539284	50 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-SUNITINIB	02552892	12.5 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-SUNITINIB	02552906	25 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
SANDOZ SUNITINIB	02532840	12.5 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ SUNITINIB	02532867	25 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ SUNITINIB	02532883	50 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SUTENT	02280795	12.5 MG	CAPSULE · ORAL	PFIZER CANADA ULC
SUTENT	02280809	25 MG	CAPSULE · ORAL	PFIZER CANADA ULC
SUTENT	02280817	50 MG	CAPSULE · ORAL	PFIZER CANADA ULC
TARO-SUNITINIB	02524058	12.5 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-SUNITINIB	02524066	25 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-SUNITINIB	02524082	50 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TEVA-SUNITINIB	02526204	12.5 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-SUNITINIB	02526212	25 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-SUNITINIB	02526220	50 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Safety signals and safety-related labeling changes

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
EMA PRAC 6 Sep 2018 PRAC signal: Aortic dissection
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Pneumatosis intestinalis
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2012 PRAC signal: Cholecystitis
Action for MAH: update of the product information: No

All safety entries for sunitinib →

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.