HEMLIBRA

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

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 more about Emicizumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
HEMLIBRA 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
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)
CA	Health Products and Food Branch	02479621, 02479648, 02479656, 02479664
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	142-MBE-1019, 144-MBE-1019
EE	Ravimiamet	1765773, 1765784, 1765795, 1765807
ES	Centro de información online de medicamentos de la AEMPS	1181271001, 1181271002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	097982, 523913, 566403, 589578
FR	Base de données publique des médicaments	61529993, 62696479
GB	Medicines & Healthcare Products Regulatory Agency	352894, 352899, 352903, 352907
HK	Department of Health Drug Office	65932, 65933, 65934, 65935
IL	מִשְׂרַד הַבְּרִיאוּת	8445, 8446, 8447, 8448
JP	医薬品医療機器総合機構	6343451A1025, 6343451A2021, 6343451A3028, 6343451A4024, 6343451A5020
LT	Valstybinė vaistų kontrolės tarnyba	1085222, 1085223, 1085224, 1085225
NG	Registered Drug Product Database	A6-100132, A6-100133, A6-100134
Switch country to Nigeria in order to find specific presentations of HEMLIBRA
NL	Z-Index G-Standaard	14018659
NL	Z-Index G-Standaard, PRK	150355, 150363, 150371, 150398
NZ	Medicines and Medical Devices Safety Authority	19403, 19404, 19441, 19442
PL	Rejestru Produktów Leczniczych	100403597, 100403670
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64640001, W64641001, W64641002, W64641003
SG	Health Sciences Authority	15576P, 15577P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505773247, 8699505773506, 8699505773544, 8699505773551
US	FDA, National Drug Code	50242-920, 50242-921, 50242-922, 50242-923
ZA	Health Products Regulatory Authority	53/30.1/0071, 53/30.1/0074