HEMLIBRA

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

Active ingredients

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

1 Emicizumab UNII 7NL2E3F6K3 - EMICIZUMAB

Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure. Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis. Read about Emicizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
HEMLIBRA 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
B02BX06		B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BX Other systemic hemostatics
Discover more medicines within B02BX06

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02479621, 02479648, 02479656, 02479664
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 142-MBE-1019, 144-MBE-1019
Country: EE	Ravimiamet	Identifier(s): 1765773, 1765784, 1765795, 1765807
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1181271001, 1181271002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 097982, 523913, 566403, 589578
Country: FR	Base de données publique des médicaments	Identifier(s): 61529993, 62696479
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 352894, 352899, 352903, 352907
Country: HK	Department of Health Drug Office	Identifier(s): 65932, 65933, 65934, 65935
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8445, 8446, 8447, 8448
Country: JP	医薬品医療機器総合機構	Identifier(s): 6343451A1025, 6343451A2021, 6343451A3028, 6343451A4024, 6343451A5020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1085222, 1085223, 1085224, 1085225
Country: NL	Z-Index G-Standaard	Identifier(s): 14018659
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 150355, 150363, 150371, 150398
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19403, 19404, 19441, 19442
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100403597, 100403670
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64640001, W64641001, W64641002, W64641003
Country: SG	Health Sciences Authority	Identifier(s): 15576P, 15577P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505773247, 8699505773506, 8699505773544, 8699505773551
Country: US	FDA, National Drug Code	Identifier(s): 50242-920, 50242-921, 50242-922, 50242-923
Country: ZA	Health Products Regulatory Authority	Identifier(s): 53/30.1/0071, 53/30.1/0074