Inclisiran
Other Lipid Modifying Agents
Sold as Leqvio
- Drug class
- Other Lipid Modifying Agents
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 6
Overview
Inclisiran is an active pharmaceutical ingredient in the Other Lipid Modifying Agents group (C10AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | May 1, 2026 |
| EU European Union | EMA | 1 | March 4, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
4 products
Uses
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.
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
How to take
4 Administration 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 INDICATIONS ............................................................................................................... 4 CONTRAINDICATIONS .................................................................................................
4 DOSAGE AND ADMINISTRATION ................................................................................. 6 OVERDOSAGE..............................................................................................................
Sources & citations
- [1]MHRA (UK) · PLGB001011202 · revised May 1, 2026
- [2]European Medicines Agency · EMEA/H/C/005333 · revised March 4, 2026
- [3]Health Canada (DPD) · 02518376 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.