Is Cabazitaxel 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 Cabazitaxel, including Anavalin (10 mg/ml, Concentrate for solution for infusion, SAR 11278.35); Cabazitaxel SPC 60mg/1.5ml (60 mg, Concentrate and solvent for solution for infusion, SAR 10756.90); JEVTANA 60 mg concentrate and solvent for solution for infusion (60 mg, Concentrate and solvent for solution for infusion, SAR 14702.10); Xatiza 60 mg / 1.5 ml (40 mg/ml, Concentrate and solvent for solution for injection, SAR 8310.35).

Is Cabazitaxel approved by the US FDA?

Drugs@FDA lists 8 application product lines for Cabazitaxel, including JEVTANA KIT (Prescription); CABAZITAXEL (Prescription); CABAZITAXEL (Prescription); CABAZITAXEL (Discontinued); CABAZITAXEL (Discontinued).

Is Cabazitaxel authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Cabazitaxel: Jevtana, Cabazitaxel Accord.

Are there safety signals or safety updates for Cabazitaxel?

EMA PRAC: 2 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2024-10-10).

Active substance

Cabazitaxel

SFDA 5
US FDA 8
EMA 3
Health Canada 5
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Anavalin	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 11278.35	Generic · Prescription	EVER Neuro Pharma GmbH	Valid
Cabazitaxel SPC 60mg/1.5ml	60 mg	Concentrate and solvent for solution for infusion · Intravenous use	1 Vial	SAR 10756.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
JEVTANA 60 mg concentrate and solvent for solution for infusion	60 mg	Concentrate and solvent for solution for infusion · Intravenous use	1 Vial	SAR 14702.10	NCE · Prescription	sanofi-aventis	Valid
Xatiza 60 mg / 1.5 ml	40 mg/ml	Concentrate and solvent for solution for injection · Intravenous use	1 Vial	SAR 8310.35	Generic · Prescription	Boston Oncology Arabia	Valid
NEUTAXAN	60 mg	Concentrate and solvent for solution for infusion · Intravenous use	1 Vial	SAR 5591.25	Generic · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
JEVTANA KIT	60MG/1.5ML (40MG/ML)	solution · intravenous	SANOFI AVENTIS US	Prescription	17 Jun 2010
CABAZITAXEL	60MG/1.5ML (40MG/ML)	solution · intravenous	ACCORD HLTHCARE	Prescription	26 Oct 2022
CABAZITAXEL	60MG/1.5ML (40MG/ML)	solution · intravenous	DR REDDYS	Prescription	10 Feb 2023
CABAZITAXEL	60MG/3ML (20MG/ML)	solution · intravenous	ACCORD HLTHCARE	Discontinued	29 Dec 2021
CABAZITAXEL	60MG/1.5ML (40MG/ML)	solution · intravenous	BRECKENRIDGE	Discontinued	23 Jun 2022
CABAZITAXEL	60MG/1.5ML (40MG/ML)	solution · intravenous	APOTEX	Discontinued	10 Feb 2023
CABAZITAXEL	60MG/1.5ML (40MG/ML)	solution · intravenous	MYLAN LABS LTD	Discontinued	5 Jul 2023
CABAZITAXEL	60MG/6ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · intravenous	ACTAVIS	Discontinued	14 Mar 2024

EMA European Union — centrally authorised medicines

Jevtana Sanofi Winthrop Industrie · Authorised · authorised 17 Mar 2011 · ATC L01CD

Therapeutic indication (EMA)

Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Cabazitaxel Accord Accord Healthcare S.L.U. · Authorised · authorised 28 Aug 2020 · ATC L01CD04

Therapeutic indication (EMA)

Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Cabazitaxel Teva Teva B.V. · Refused · ATC L01CD04

Therapeutic indication (EMA)

Treatment of prostate cancer

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CABAZITAXEL FOR INJECTION	02487497	45 MG / 4.5 ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
CABAZITAXEL FOR INJECTION	02487500	60 MG / 6 ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
CABAZITAXEL FOR INJECTION	02495635	40 MG / ML	SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
CABAZITAXEL FOR INJECTION	02553783	45 MG / 4.5 ML	SOLUTION · INTRAVENOUS	FORMATIVE PHARMA INC.
CABAZITAXEL FOR INJECTION	02553791	60 MG / 6 ML	SOLUTION · INTRAVENOUS	FORMATIVE PHARMA INC.

Safety signals and safety-related labeling changes

US FDA 10 Oct 2024 CABAZITAXEL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jul 2023 JEVTANA KIT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Cabazitaxel (Jevtana▼): risk of medication error resulting in overdose
It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel. It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel Pharmacies should review worksheets used in the preparation of cabazitaxel to ensure that they inform pharmacy staff to add the entire contents of the solvent vial to the concentrate vial
EMA PRAC 5 Dec 2013 PRAC signal: Medication error potentially leading to inappropriate dose
Action for MAH: update of the product information: No
EMA PRAC 10 Oct 2013 PRAC signal: Medication error potentially leading to inappropriate dose
Action for MAH: update of the product information: No

All safety entries for cabazitaxel →

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.