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, Netherlands, New Zealand, Poland, Romania, Spain, Turkey, UK.
The drug BEXSERO contains a combination of these active pharmaceutical ingredients (APIs):
1
|
UNII
28E911Y7AE - NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN
|
2
|
UNII
1S25R442RS - NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN
|
3
|
UNII
25DB599G64 - NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN
|
4
|
UNII
91523M4S24 - NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| BEXSERO Suspension for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07AH09 | Meningococcus B, multicomponent vaccine | J Antiinfectives for systemic use → J07 Vaccines → J07A Bacterial vaccines → J07AH Meningococcal 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 | 510616090056017, 510616090056117, 510616090056217 |
| CA | Health Products and Food Branch | 02417030 |
| EE | Ravimiamet | 1606092, 1606104, 1856527 |
| ES | Centro de información online de medicamentos de la AEMPS | 112812001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 539174 |
| FR | Base de données publique des médicaments | 64493883 |
| GB | Medicines & Healthcare Products Regulatory Agency | 235843, 374307, 390439 |
| HK | Department of Health Drug Office | 66268 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7867 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1069333, 1069334, 1069335, 1069336 |
| NL | Z-Index G-Standaard, PRK | 153575 |
| NZ | Medicines and Medical Devices Safety Authority | 19497 |
| PL | Rejestru Produktów Leczniczych | 100127068 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W62936001, W62936002, W62936003, W62936004 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522965014, 8699522965021, 8699522965038 |
| US | FDA, National Drug Code | 58160-976 |
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