This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, France, Italy, Lithuania, UK.
The drug AREXVY contains one active pharmaceutical ingredient (API):
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Respiratory syncytial virus vaccine is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus. There are three types of RSV vaccine. The first one is a bivalent, recombinant vaccine, containing two recombinant stabilised RSV prefusion F antigens representing subgroups RSV-A and RSV-B. The second one is a RSVPreF3 vaccine which combines the RSV-specific antigen with an adjuvant system (AS01E), designed to enhance antigen-specific cellular immune response and neutralizing antibodies response in individuals with pre-existing immunity against RSV, and an mRNA-based vaccine that stimulates production of RSV-A and RSV-B neutralising antibodies and induction of antigen-specific cellular immune responses. |
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Below package inserts are available for further reading:
Document | Type | Information Source | |
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AREXVY Powder for 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 | |
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J07BX05 | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BX Other viral vaccines | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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EE | Ravimiamet | 3040399, 3040401 |
FI | Lääkealan turvallisuus- ja kehittämiskeskus | 041312 |
FR | Base de données publique des médicaments | 64431629 |
IT | Agenzia del Farmaco | 050751015, 050751027 |
LT | Valstybinė vaistų kontrolės tarnyba | 1097246, 1097247 |
US | FDA, National Drug Code | 58160-723, 58160-744, 58160-848 |
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