Is Inclisiran 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 Inclisiran, including LEQVIO (284 mg, Solution for injection/infusion in pre-filled syringe, SAR 9954.50).

Is Inclisiran approved by the US FDA?

Drugs@FDA lists 1 application product line for Inclisiran, including LEQVIO (Prescription).

Is Inclisiran authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Inclisiran: Leqvio.

Are there safety signals or safety updates for Inclisiran?

US FDA: 1 entry (latest 2026-08-19).

Active substance

Inclisiran

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
LEQVIO	284 mg	Solution for injection/infusion in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 9954.50	NCE · Prescription	Novartis Europharm Limited	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	solution · subcutaneous	NOVARTIS	Prescription	22 Dec 2021

EMA European Union — centrally authorised medicines

Leqvio Novartis Europharm Limited · Authorised · authorised 9 Dec 2020 · ATC C10AX

Therapeutic indication (EMA)

Leqvio 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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LEQVIO	02518376	284 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 19 Aug 2026 LEQVIO — 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 inclisiran →

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.