PRALUENT
As listed in the register: PRALUENT 150 mg, solution injectable en stylo prérempli
150 mg · solution injectable
- Prescription only
- 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
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
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
Safety of the active substance
From the US prescribing label for the same active substance (Praluent). It describes the substance, not this exact product.
- PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT.
- Hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see Warnings and Precautions (5.1) ].
- History of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT.
The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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 States2 matching products
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | SANOFI WINTHROP INDUSTRIE |
|---|---|
| Active substance | Alirocumab |
| Strength | 150 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services NEUROLOGIE · prescription réservée aux spécialistes et services ENDOCRINOLOGIE · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services DIABETOLOGIE · prescription réservée aux spécialistes et services CARDIOLOGIE · prescription initiale annuelle réservée à certains spécialistes · liste I · prescription réservée aux médecins compétents en NUTRITION · prescription réservée aux spécialistes et services MEDECINE VASCULAIRE · renouvellement non restreint |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/15/1031 |
| Name in the register | PRALUENT 150 mg, solution injectable en stylo prérempli |
| Packs | 2 seringue(s) préremplie(s) en verre de 1 ml avec aiguille(s) dans stylo pré-rempli |
| CIS | 68788824 |
| CIP13 | 3400930034392 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.