Is Pazopanib 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 Pazopanib, including PORENZA (200 mg, Film-coated tablet, SAR 1183.40); PORENZA (400 mg, Film-coated tablet, SAR 2716.80); VOTRIENT (200 mg, Film-coated tablet, SAR 1267.95); VOTRIENT (400 mg, Film-coated tablet, SAR 2910.90).

Is Pazopanib approved by the US FDA?

Drugs@FDA lists 8 application product lines for Pazopanib, including VOTRIENT (Prescription); PAZOPANIB HYDROCHLORIDE (Prescription); PAZOPANIB HYDROCHLORIDE (Prescription); PAZOPANIB HYDROCHLORIDE (Prescription); PAZOPANIB HYDROCHLORIDE (Prescription).

Is Pazopanib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pazopanib: Votrient.

Are there safety signals or safety updates for Pazopanib?

EMA PRAC: 7 entries; US FDA: 1 entry (latest 2024-01-25).

Active substance

Pazopanib

SFDA 6
US FDA 8
EMA 1
Health Canada 3
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PORENZA	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 1183.40	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
PORENZA	400 mg	Film-coated tablet · Oral use	30 Bottle	SAR 2716.80	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
VOTRIENT	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 1267.95	NCE · Prescription	NOVARTIS PHARMA AG	Valid
VOTRIENT	400 mg	Film-coated tablet · Oral use	30 Bottle	SAR 2910.90	NCE · Prescription	NOVARTIS PHARMA AG	Valid
VOTRIENT	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 3511.45	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
VOTRIENT	400 mg	Film-coated tablet · Oral use	30 Bottle	SAR 7022.00	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; THYROID CANCER-PAPILLARY, FOLLICULAR, HURTHLE CELL CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
VOTRIENT	EQ 200MG BASE	tablet · oral	NOVARTIS	Prescription	19 Oct 2009
PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	tablet · oral	SUN PHARM	Prescription	19 Oct 2023
PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	tablet · oral	TEVA PHARMS INC	Prescription	19 Oct 2023
PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	tablet · oral	APOTEX	Prescription	19 Oct 2023
PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	tablet · oral	NOVUGEN	Prescription	23 Apr 2024
PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	tablet · oral	EUGIA PHARMA	Prescription	4 Dec 2024
PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	tablet · oral	TORRENT	Prescription	4 Sep 2025
VOTRIENT	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	NOVARTIS	Discontinued	19 Oct 2009

EMA European Union — centrally authorised medicines

Votrient Novartis Europharm Limited · Authorised · authorised 14 Jun 2010 · ATC L01XE11

Therapeutic indication (EMA)

Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-PAZOPANIB	02552957	200 MG	TABLET · ORAL	AURO PHARMA INC
PMS-PAZOPANIB	02525666	200 MG	TABLET · ORAL	PHARMASCIENCE INC
VOTRIENT	02352303	200 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 25 Jan 2024 VOTRIENT — 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 31 Oct 2019 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
EMA PRAC 6 Sep 2018 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
EMA PRAC 9 Jun 2016 PRAC signal: Polycythaemia
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2014 PRAC signal: Retinal detachment and retinal tear
Action for MAH: update of the product information: No

All safety entries for pazopanib →

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.