PRALUENT

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

Active ingredients

The drug PRALUENT contains one active pharmaceutical ingredient (API):

1 Alirocumab UNII PP0SHH6V16 - ALIROCUMAB

Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels. Read about Alirocumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PRALUENT Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
C10AX14		C Cardiovascular system → C10 Lipid modifying agents → C10A Lipid modifying agents, plain → C10AX Other lipid modifying agents
Discover more medicines within C10AX14

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 576720040063617, 576720040063717, 576720040063817, 576720040063917, 576720040064017, 576720040064117
Country: CA	Health Products and Food Branch	Identifier(s): 02453754, 02453762, 02453819, 02453835
Country: EE	Ravimiamet	Identifier(s): 1698059, 1698060, 1698071, 1698082, 1698093, 1698105, 1698116, 1698127, 1698138, 1698149, 1698150, 1698161, 1826186, 1826197
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151031002, 1151031008, 1151031019
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 084948, 400080
Country: FR	Base de données publique des médicaments	Identifier(s): 60570108, 68788824
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 308409, 308410, 308422, 308424, 394797
Country: HK	Department of Health Drug Office	Identifier(s): 64761, 64762
Country: IE	Health Products Regulatory Authority	Identifier(s): 89070, 89071
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7836, 7837
Country: IT	Agenzia del Farmaco	Identifier(s): 044500015, 044500027, 044500039, 044500041, 044500054, 044500066, 044500078, 044500080, 044500092, 044500104, 044500116, 044500128, 044500130, 044500142, 044500155, 044500167, 044500179, 044500181, 044500193, 044500205
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1078408, 1078409, 1078410, 1078411, 1078412, 1078413, 1078414, 1078415, 1078416, 1078417, 1078418, 1078419, 1091040, 1091041, 1091042, 1091043, 1091044, 1091045, 1091046, 1091047
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 131326, 131334
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18111, 18112
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100353050, 100353066, 100443183
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69331001, W69331002, W69332001, W69332002, W69333001, W69333002, W69334001, W69334002, W69335001
Country: SG	Health Sciences Authority	Identifier(s): 15228P, 15229P, 15809P, 15810P
Country: US	FDA, National Drug Code	Identifier(s): 0024-5901, 0024-5902, 0024-5903, 0024-5904, 61755-020, 61755-021, 72733-5901, 72733-5902