Is Sebelipase alfa 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 Sebelipase alfa, including KANUMA (2 mg/ml, Concentrate for solution for infusion, SAR 32606.95).

Is Sebelipase alfa approved by the US FDA?

Drugs@FDA lists 1 application product line for Sebelipase alfa, including KANUMA (Prescription).

Is Sebelipase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sebelipase alfa: Kanuma.

Are there safety signals or safety updates for Sebelipase alfa?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2024-07-10).

Active substance

Sebelipase alfa

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
KANUMA	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 32606.95	Biological · Prescription	Alexion Europe SAS	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
KANUMA	20MG/10ML	injectable · injection	ALEXION PHARM	Prescription	8 Dec 2015

EMA European Union — centrally authorised medicines

Kanuma Alexion Europe SAS · Authorised · authorised 28 Aug 2015 · ATC A16

Therapeutic indication (EMA)

Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KANUMA	02469596	2 MG / ML	SOLUTION · INTRAVENOUS	ALEXION PHARMA GMBH

Safety signals and safety-related labeling changes

US FDA 10 Jul 2024 KANUMA — 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
EMA PRAC 3 Oct 2019 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No

All safety entries for sebelipase alfa →

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.