Praluent
- Prescription status not stated
- Heart, blood pressure and circulation
- Active substance
- Alirocumab
- Made by
- Sanofi Winthrop Industrie
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Praluent). It describes the substance, not this exact product.
Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9).
PCSK9 binds to the low-density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.
Renal Impairment Since monoclonal antibodies are not known to be eliminated via renal pathways, renal function is not expected to impact the pharmacokinetics of alirocumab.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-16
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sanofi Winthrop Industrie |
|---|---|
| Active substance | Alirocumab |
| Used in | Heart, blood pressure and circulation |
| Classification | C10AX14 · Heart, blood pressure and circulation |
| Authorised on | 2015-09-23 |
| Last updated by the regulator | 2026-01-09 |
| EMA product number | EMEA/H/C/003882 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).