REPATHA

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

Active ingredients

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

1 Evolocumab UNII LKC0U3A8NJ - EVOLOCUMAB

Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C). Read about Evolocumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
REPATHA 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
C10AX13		C Cardiovascular system → C10 Lipid modifying agents → C10A Lipid modifying agents, plain → C10AX Other lipid modifying agents
Discover more medicines within C10AX13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10958R, 11193D, 11484K, 11485L, 11972D, 11977J, 11985T, 11986W
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 544116080003101, 544116080003201, 544116080003301, 544116080003401
Country: CA	Health Products and Food Branch	Identifier(s): 02446057, 02459779
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 155-MBE-0520
Country: EE	Ravimiamet	Identifier(s): 1693245, 1693256, 1693267, 1693278, 1693289, 1741092, 1741104
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151016002, 1151016003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 553814
Country: FR	Base de données publique des médicaments	Identifier(s): 60966449
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 306640
Country: HK	Department of Health Drug Office	Identifier(s): 64509, 64510
Country: IE	Health Products Regulatory Authority	Identifier(s): 88993
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7838
Country: IT	Agenzia del Farmaco	Identifier(s): 044317016, 044317028, 044317030, 044317042, 044317055, 044317067, 044317079
Country: JP	医薬品医療機器総合機構	Identifier(s): 2189401G2026, 2189401G3022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1077710, 1077711, 1077712, 1077713, 1077714, 1082472, 1082473
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 129682
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19405, 19440
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100345061, 100388521
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62419001
Country: SG	Health Sciences Authority	Identifier(s): 15223P, 15224P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699862950152, 8699862950169, 8699862950176, 8699862950183
Country: US	FDA, National Drug Code	Identifier(s): 55513-750, 55513-760, 72511-750, 72511-760