ENGERIX-B

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

Active ingredients

The drug ENGERIX-B contains one active pharmaceutical ingredient (API):

1 Hepatitis B, purified antigen UNII 9GCJ1L5D1P - HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer. Read about Hepatitis B, purified antigen

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ENGERIX-B Suspension for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
J07BC01	Hepatitis B, purified antigen	J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BC Hepatitis vaccines
Discover more medicines within J07BC01

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): 510602503158310, 510602505150317, 510615020053803
Country: CA	Health Products and Food Branch	Identifier(s): 02487020, 02487039
Country: EE	Ravimiamet	Identifier(s): 1009325, 1065158, 1065169, 1065170, 1065181, 1065192, 1065215
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 60652, 60653
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 108328, 576544
Country: FR	Base de données publique des médicaments	Identifier(s): 62279329, 65782652
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 29917, 29921, 30206
Country: HK	Department of Health Drug Office	Identifier(s): 49501, 65374, 65375
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-287121380, HR-H-891298860
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 983, 984
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1009881, 1009882, 1009883, 1009884, 1009885, 1014143, 1014144
Country: MT	Medicines Authority	Identifier(s): MA192/02101, MA192/02102, PI1438/02101A, PI1438/02102A, PI1438/02103A
Country: NL	Z-Index G-Standaard	Identifier(s): 14149494, 14624362
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 48321, 58327, 92975
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14054, 4930
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100196046, 100224268
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W52082001, W52082002, W52082003, W52082004, W52082005, W52082006, W52082008, W52082009, W52082010, W52082011, W52082012, W52082013, W52082014, W52082015, W52082016, W52082017, W52082018, W52085001, W52085002, W52085003, W52085004, W52085005, W52085006, W52085007, W52085009, W52085010, W52085011, W52085012, W52085013, W52085014, W52085015, W52085016, W52085017, W52085018, W52085019, W52085020
Country: SG	Health Sciences Authority	Identifier(s): 02234P, 15807P, 15808P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699522964307, 8699522964314, 8699522964321, 8699522964338, 8699522964345, 8699522964352, 8699522964369, 8699522964376, 8699522967117, 8699522967216
Country: US	FDA, National Drug Code	Identifier(s): 50090-1706, 58160-820, 58160-821
Country: ZA	Health Products Regulatory Authority	Identifier(s): U/30.1/186, W/30.1/35