Is Axitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Axitinib, including INLYTA 1 mg film-coated tablet (1 mg, Film-coated tablet, SAR 3095.15); INLYTA 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 15281.40).

Is Axitinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Axitinib, including INLYTA (Prescription); AXITINIB (Prescription).

Is Axitinib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Axitinib: Inlyta, Axitinib Accord.

Are there safety signals or safety updates for Axitinib?

EMA PRAC: 5 entries; US FDA: 1 entry (latest 2024-07-16).

Active substance

Axitinib

SFDA 2
US FDA 2
EMA 2
Health Canada 2
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
INLYTA 1 mg film-coated tablet	1 mg	Film-coated tablet · Oral use	56 Blister	SAR 3095.15	NCE · Prescription	Pfizer Europe MA EEIG	Valid
INLYTA 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	56 Blister	SAR 15281.40	NCE · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

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
INLYTA	1MG; 5MG	tablet · oral	PF PRISM CV	Prescription	27 Jan 2012
AXITINIB	1MG; 5MG	tablet · oral	APOTEX	Prescription	30 Oct 2025

EMA European Union — centrally authorised medicines

Inlyta Pfizer Europe MA EEIG · Authorised · authorised 3 Sep 2012 · ATC L01EK01

Therapeutic indication (EMA)

Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Axitinib Accord Accord Healthcare S.L.U. · Authorised · authorised 19 Sep 2024 · ATC L01EK01

Therapeutic indication (EMA)

Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INLYTA	02389630	1 MG	TABLET · ORAL	PFIZER CANADA ULC
INLYTA	02389649	5 MG	TABLET · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 16 Jul 2024 INLYTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; 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 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 17 Mar 2016 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2015 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No

All safety entries for axitinib →

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.