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Nabriva Therapeutics Ireland DACEU/1/20/1457/002

Main Information

Trade NameXenleta
Active SubstancesLefamulin
Dosage FormFilm-coated tablet
Licence HolderNabriva Therapeutics Ireland DAC
Licence NumberEU/1/20/1457/002

Group Information

ATC CodeJ01XX Other antibacterials
J01XX12 lefamulin


License statusAuthorised
Licence Issued27/07/2020
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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