REPATHA

This brand name is authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK, 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 more about Evolocumab

Medication package inserts

Below package inserts are available for further reading:

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