HIZENTRA

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

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 about Human normal immunoglobulin G

Medication package inserts

Below package inserts are available for further reading:

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