EMA · European Union
lefamulin — EMA regulatory status
lefamulin (XENLETA) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- XENLETA
- Structured fields
- 4
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 1 published clinical program and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| lefamulin | Phase 3 | Nabriva Therapeutics | NCT02813694 |
Related hubs
FAQ
What is the EMA approval status of lefamulin?
lefamulin currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get lefamulin regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to lefamulin?
This spoke lists 1 published program associated with lefamulin in our pipeline index.