Is Evinacumab 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 Evinacumab, including Evkeeza (150 mg/ml, Concentrate for solution for infusion, SAR 32644.35).

Is Evinacumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Evinacumab, including EVKEEZA (Prescription).

Is Evinacumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Evinacumab: Evkeeza.

Are there safety signals or safety updates for Evinacumab?

US FDA: 1 entry (latest 2025-09-25).

Active substance

Evinacumab

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
Evkeeza	150 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 32644.35	Biological · Prescription	Ultragenyx Germany	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
EVKEEZA	345MG/2.3ML; 1200MG/8ML	solution · injection	REGENERON PHARMACEUTICALS	Prescription	11 Feb 2021

EMA European Union — centrally authorised medicines

Evkeeza Ultragenyx Germany GmbH · Authorised · authorised 17 Jun 2021 · ATC C10AX

Therapeutic indication (EMA)

Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EVKEEZA	02541769	150 MG / ML	SOLUTION · INTRAVENOUS	ULTRAGENYX PHARMACEUTICAL INC

Safety signals and safety-related labeling changes

US FDA 25 Sep 2025 EVKEEZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for evinacumab →

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.