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

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