Is Rasburicase 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 Rasburicase, including Fasturtec (1.5 mg, Powder and solvent for solution for infusion, SAR 979.75); Fasturtec (7.5 mg, Powder and solvent for solution for infusion, SAR 1632.90).

Is Rasburicase approved by the US FDA?

Drugs@FDA lists 1 application product line for Rasburicase, including ELITEK (Prescription).

Is Rasburicase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rasburicase: Fasturtec.

Is Rasburicase on the WHO Model List of Essential Medicines?

Yes — 8.2.5. Supportive medicines (complementary list): Tumour lysis syndrome.

Are there safety signals or safety updates for Rasburicase?

US FDA: 1 entry (latest 2019-12-12).

Active substance

Rasburicase

SFDA 2
US FDA 1
EMA 1
Health Canada 1
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Fasturtec	1.5 mg	Powder and solvent for solution for infusion · Intravenous use	3 Vial	SAR 979.75	Biological · Prescription	Sanofi Aventis France	Valid
Fasturtec	7.5 mg	Powder and solvent for solution for infusion · Intravenous use	1 Vial	SAR 1632.90	Biological · Prescription	Sanofi Aventis France	Valid

Indications — CHI Daman Drug Formulary

BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); DISORDERS OF PURINE AND PYRIMIDINE METABOLISM; FOLLICULAR LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; PEDIATRIC B-CELL LYMPHOMA; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ELITEK	1.5MG/VIAL	vial · intravenous	SANOFI SYNTHELABO	Prescription	12 Jul 2002

EMA European Union — centrally authorised medicines

Fasturtec Sanofi Winthrop Industrie · Authorised · authorised 23 Feb 2001 · ATC V03AF07

Therapeutic indication (EMA)

Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FASTURTEC	02248416	1.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

WHO WHO Model List of Essential Medicines (2025)

8.2.5. Supportive medicines · complementary
Tumour lysis syndrome
Parenteral > General injections > IV: 1.5 mg in vial powder and 1 mL solvent for solution; 7.5 mg in vial powder and 5 mL solvent for solution

Safety signals and safety-related labeling changes

US FDA 12 Dec 2019 ELITEK — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rasburicase →

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.