Is Imiglucerase 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 Imiglucerase, including CEREZYME 400 U powder for concentrate for solution for infusion (400 U, Powder for concentrate for solution for infusion, SAR 5984.85).

Is Imiglucerase approved by the US FDA?

Drugs@FDA lists 1 application product line for Imiglucerase, including CEREZYME (Prescription).

Is Imiglucerase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Imiglucerase: Cerezyme.

Are there safety signals or safety updates for Imiglucerase?

US FDA: 1 entry (latest 2026-01-12).

Active substance

Imiglucerase

SFDA 1
US FDA 1
EMA 1
Health Canada 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
CEREZYME 400 U powder for concentrate for solution for infusion	400 U	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 5984.85	Biological · Prescription	Sanofi B.V	Valid

Indications — CHI Daman Drug Formulary

GAUCHER DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
CEREZYME	200 UNITS/VIAL; 400 UNITS/VIAL	injectable · injection	GENZYME	Prescription	23 May 1994

EMA European Union — centrally authorised medicines

Cerezyme Sanofi B.V. · Authorised · authorised 17 Nov 1997 · ATC A16AB02

Therapeutic indication (EMA)

Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: anaemia after exclusion of other causes, such as iron deficiency Thrombocytopenia Bone disease after exclusion of other causes such as Vitamin D deficiency hepatomegaly or splenomegaly

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CEREZYME	02241751	400 UNIT / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 12 Jan 2026 CEREZYME — 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

All safety entries for imiglucerase →

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.