PRALUENT

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

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 more about Alirocumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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