HIZENTRA

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

Active ingredients

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

1	Human normal immunoglobulin G UNII 66Y330CJHS - HUMAN IMMUNOGLOBULIN G
	Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors.
	Read more about Human normal immunoglobulin G

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
HIZENTRA 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
J06BA01	Immunoglobulins, normal human, for extravascular adm.	J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BA Immunoglobulins, normal human
Discover more medicines within J06BA01

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	502615120007603, 502615120007703, 502615120007803, 502620120010207, 502620120010307, 502620120010407
CA	Health Products and Food Branch	02370352, 02463059, 02463067
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	59-MBE-0616
EE	Ravimiamet	1527656, 1527667, 1527678, 1527689, 1527690, 1527702, 1527713, 1527724, 1527735, 1527746, 1527757, 1527768, 1636691, 1636703, 1636714, 1764299, 1764301, 1764323, 1764334
ES	Centro de información online de medicamentos de la AEMPS	111687014, 11687002, 11687005, 11687012
FI	Lääkealan turvallisuus- ja kehittämiskeskus	139631, 160701, 167315, 426888, 572463
FR	Base de données publique des médicaments	61181266
GB	Medicines & Healthcare Products Regulatory Agency	194670, 194674, 194678, 353243
HK	Department of Health Drug Office	65093, 65094, 65095, 65096
JP	医薬品医療機器総合機構	6343439A1024, 6343439A2020, 6343439A3027
LT	Valstybinė vaistų kontrolės tarnyba	1059898, 1059899, 1059900, 1059901, 1059902, 1059903, 1059907, 1059908, 1059909, 1071232, 1071233, 1084552, 1084553, 1084554, 1084555, 1091109, 1091110
NL	Z-Index G-Standaard, PRK	203955, 206113, 97381, 97403, 97411
NZ	Medicines and Medical Devices Safety Authority	16223
PL	Rejestru Produktów Leczniczych	100248748
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W60116001, W60116002, W60116003, W60116004, W60116005, W60116006, W60116007, W60116008, W60116009, W60116010, W60116011, W60116012
SG	Health Sciences Authority	15499P
TR	İlaç ve Tıbbi Cihaz Kurumu	8681624980200, 8681624980217, 8681624980224, 8681624980279
US	FDA, National Drug Code	44206-451, 44206-452, 44206-454, 44206-455, 44206-456, 44206-457, 44206-458