Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Nabriva Therapeutics Ireland DAC, Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland
Xenleta 600 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Blue, oval, film-coated tablet with ‘LEF 600’ printed in black on one side. |
Each tablet contains lefamulin acetate equivalent to 600 mg of lefamulin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lefamulin |
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. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Tablet coating: Poly(vinyl alcohol) (partially hydrolysed) (E1203) Tablet printing: Shellac |
One pack contains: PVC/PE/PCTFE / Aluminium blisters with 10 film-coated tablets.
Nabriva Therapeutics Ireland DAC, Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland
EU/1/20/1457/002
Date of first authorisation: 27 July 2020
| Drug | Countries | |
|---|---|---|
| XENLETA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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