This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug ENGERIX-B contains one active pharmaceutical ingredient (API):
1
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UNII
9GCJ1L5D1P - HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ENGERIX-B Suspension for injection | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07BC01 | Hepatitis B, purified antigen | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BC Hepatitis vaccines |
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 | 510602503158310, 510602505150317, 510615020053803 |
| CA | Health Products and Food Branch | 02487020, 02487039 |
| EE | Ravimiamet | 1009325, 1065158, 1065169, 1065170, 1065181, 1065192, 1065215 |
| ES | Centro de información online de medicamentos de la AEMPS | 60652, 60653 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 108328, 576544 |
| FR | Base de données publique des médicaments | 62279329, 65782652 |
| GB | Medicines & Healthcare Products Regulatory Agency | 29917, 29921, 30206 |
| HK | Department of Health Drug Office | 49501, 65374, 65375 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-287121380, HR-H-891298860 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 983, 984 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1009881, 1009882, 1009883, 1009884, 1009885, 1014143, 1014144 |
| MT | Medicines Authority | MA192/02101, MA192/02102, PI1438/02101A, PI1438/02102A, PI1438/02103A |
| NG | Registered Drug Product Database | A6-0041 |
| NL | Z-Index G-Standaard | 14149494, 14624362 |
| NL | Z-Index G-Standaard, PRK | 48321, 58327, 92975 |
| NZ | Medicines and Medical Devices Safety Authority | 14054, 4930 |
| PL | Rejestru Produktów Leczniczych | 100196046, 100224268 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | 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 |
| SG | Health Sciences Authority | 02234P, 15807P, 15808P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522964307, 8699522964314, 8699522964321, 8699522964338, 8699522964345, 8699522964352, 8699522964369, 8699522964376, 8699522967117, 8699522967216 |
| US | FDA, National Drug Code | 50090-1706, 58160-820, 58160-821 |
| ZA | Health Products Regulatory Authority | U/30.1/186, W/30.1/35 |
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