Is Evolocumab 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 Evolocumab, including REPATHA 140 mg/ml Solution For Injection (140 mg/ml, Solution for injection, SAR 1758.45).

Is Evolocumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Evolocumab, including REPATHA (Prescription).

Is Evolocumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Evolocumab: Repatha.

Are there safety signals or safety updates for Evolocumab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2024-11-20).

Active substance

Evolocumab

SFDA 3
US FDA 1
EMA 1
Health Canada 1
US price lines 2
NHS prices 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
REPATHA 140 mg/ml Solution For Injection	140 mg/ml	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 1758.45	Biological · Prescription	AMGEN EUROPE B.V.	Valid
REPATHA 140 mg/ml Solution For Injection	140 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 936.55	Biological · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed
REPATHA 420 mg Solution for Injection in Cartridge	420 mg	Solution for injection · Subcutaneous use	1 Cartridge	SAR 1758.45	Biological · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; DYSLIPIDEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
REPATHA	140MG/ML	injectable · injection	AMGEN INC	Prescription	27 Aug 2015

EMA European Union — centrally authorised medicines

Repatha Amgen Europe B.V. · Authorised · authorised 17 Jul 2015 · ATC C10AX13

Therapeutic indication (EMA)

Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REPATHA	02446057	140 MG / ML	SOLUTION · SUBCUTANEOUS	AMGEN CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	REPATHA 140 MG/ML SURECLICK	$281.96114	per ML	23 Sep 2026
US NADAC	REPATHA 140 MG/ML SYRINGE	$281.80579	per ML	23 Sep 2026
NHS Drug Tariff	Evolocumab 140mg/1ml solution for injection pre-filled disposable devices	£340.20	2 pre-filled disposable injection	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 20 Nov 2024 REPATHA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 14 Apr 2023 PRAC signal: Weight increase and abnormal weight gain
Action for MAH: update of the product information: No
EMA PRAC 1 Dec 2022 PRAC signal: Weight increase and abnormal weight gain
Action for MAH: update of the product information: No

All safety entries for evolocumab →

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.