Is Pegaspargase registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Pegaspargase, including Oncaspar (750 IU/ml, Powder for solution for injection/infusion, SAR 8368.30).

Is Pegaspargase approved by the US FDA?

Drugs@FDA lists 1 application product line for Pegaspargase, including ONCASPAR (Prescription).

Is Pegaspargase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegaspargase: Oncaspar.

Is Pegaspargase on the WHO Model List of Essential Medicines?

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

Are there safety signals or safety updates for Pegaspargase?

US FDA: 1 entry (latest 2024-03-13).

Active substance

Pegaspargase

SFDA 1
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
Oncaspar	750 IU/ml	Powder for solution for injection/infusion · Intramuscular and intravenous use	1 Vial	SAR 8368.30	Biological · Prescription	LES LABORATOIRES SERVIER	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
ONCASPAR	750IU/VIAL	vial	SIGMA TAU	Prescription	1 Feb 1994

EMA European Union — centrally authorised medicines

Oncaspar Les Laboratoires Servier · Authorised · authorised 14 Jan 2016 · ATC L01XX24

Therapeutic indication (EMA)

Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ONCASPAR	02461900	750 UNIT / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SERVIER CANADA INC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · core
Lymphoid leukaemia, not elsewhere classified
Parenteral > General injections > IV: 3750 units per 5 mL in vial; 3750 units in vial powder for injection

Safety signals and safety-related labeling changes

US FDA 13 Mar 2024 ONCASPAR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pegaspargase →

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.