Is Alirocumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Alirocumab, including PRALUENT 150 mg Prefilled Pen (150 mg, Solution for injection in pre-filled pen, SAR 1755.00); PRALUENT 150 mg Prefilled Syringe (150 mg, Solution for injection in pre-filled syringe, SAR 936.55); PRALUENT 75 mg Prefilled Pen (75 mg, Solution for injection in pre-filled pen, SAR 936.55); PRALUENT 75 mg Prefilled Syringe (75 mg, Solution for injection in pre-filled syringe, SAR 936.55); Praluent 300 mg per 2 ml (150 mg/ml, Solution for injection, SAR 1873.10).

Is Alirocumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Alirocumab, including PRALUENT (Prescription).

Is Alirocumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alirocumab: Praluent.

Are there safety signals or safety updates for Alirocumab?

US FDA: 1 entry (latest 2025-10-09).

Active substance

Alirocumab

SFDA 9
US FDA 1
EMA 1
Health Canada 3
US price lines 2
NHS prices 2
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
PRALUENT 150 mg Prefilled Pen	150 mg	Solution for injection in pre-filled pen · Subcutaneous use	2 Pre-filled pen	SAR 1755.00	Biological · Prescription	sanofi-aventis	Valid
PRALUENT 150 mg Prefilled Pen	150 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 936.55	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
PRALUENT 150 mg Prefilled Syringe	150 mg	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 936.55	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
PRALUENT 150 mg Prefilled Syringe	150 mg	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 1873.10	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
PRALUENT 75 mg Prefilled Pen	75 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 936.55	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
PRALUENT 75 mg Prefilled Pen	75 mg	Solution for injection in pre-filled pen · Subcutaneous use	2 Pre-filled pen	SAR 1755.00	Biological · Prescription	sanofi-aventis	Valid
PRALUENT 75 mg Prefilled Syringe	75 mg	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 936.55	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
PRALUENT 75 mg Prefilled Syringe	75 mg	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 1873.10	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
Praluent 300 mg per 2 ml	150 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 1873.10	Biological · Prescription	Sanofi Clir SNC	Valid

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
PRALUENT	75MG; 150MG	injectable · injection	REGENERON PHARMACEUTICALS	Prescription	24 Jul 2015

EMA European Union — centrally authorised medicines

Praluent Sanofi Winthrop Industrie · Authorised · authorised 23 Sep 2015 · ATC C10AX14

Therapeutic indication (EMA)

Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular 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
PRALUENT	02453819	75 MG / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
PRALUENT	02453835	150 MG / ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
PRALUENT	02547732	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PRALUENT 150 MG/ML PEN	$258.00732	per ML	23 Sep 2026
US NADAC	PRALUENT 75 MG/ML PEN	$257.7316	per ML	23 Sep 2026
NHS Drug Tariff	Alirocumab 150mg/1ml solution for injection pre-filled disposable devices	£336.00	2 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Alirocumab 75mg/1ml solution for injection pre-filled disposable devices	£336.00	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 9 Oct 2025 PRALUENT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alirocumab →

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.