Is Asparaginase registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Asparaginase.

Is Asparaginase approved by the US FDA?

Drugs@FDA lists 1 application product line for Asparaginase, including ELSPAR (Prescription).

Is Asparaginase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Asparaginase: Spectrila.

Is Asparaginase on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (core list): Lymphoid leukaemia, not elsewhere classified.

Active substance

Asparaginase

SFDA 1
US FDA 1
EMA 2
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
KIDROLASE 10000 U-2.5ML VIAL	10000 IU	Solution · Intravenous use	1 Vial	SAR 115.55	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ELSPAR	10,000IU/VIAL	vial	MERCK	Prescription	10 Jan 1978

EMA European Union — centrally authorised medicines

Spectrila Medac Gesellschaft fuer klinische Spezialpraeparate mbH · Authorised · authorised 14 Jan 2016 · ATC L01XX02

Therapeutic indication (EMA)

Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.

Graspa ERYTECH Pharma S.A. · Application withdrawn · authorised 27 Jun 2018 · ATC LX1XX02

Therapeutic indication (EMA)

Treatment of acute lymphoblastic leukaemia

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · core
Lymphoid leukaemia, not elsewhere classified
Parenteral > General injections > unspecified: 10000 IU in vial powder for injection

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.