This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Ireland, Italy, Lithuania, Poland.
The drug XENLETA contains one active pharmaceutical ingredient (API):
1
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UNII
HDN0B924X4 - LEFAMULIN ACETATE
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Lefamulin is a pleuromutilin antibacterial agent. It inhibits bacterial protein synthesis by interacting with the A- and P- sites of the peptidyl transferase centre (PTC) in the central part of domain V of the 23S rRNA of the 50S ribosomal subunit, preventing correct positioning of the tRNA. |
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Below package inserts are available for further reading:
Document | Type | Information Source | |
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XENLETA Concentrate and solvent for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) | |
XENLETA Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) | |
XENLETA Solution for injection / Film-coated tablet | 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 | |
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J01XX12 | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01X Other antibacterials → J01XX Other antibacterials | |
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 | 1824454, 1824465 |
IT | Agenzia del Farmaco | 048963019, 048963021 |
LT | Valstybinė vaistų kontrolės tarnyba | 1090897, 1090898 |
PL | Rejestru Produktów Leczniczych | 100440180, 100440196 |
US | FDA, National Drug Code | 72000-110, 72000-120 |
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