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Xenleta

Active substance: lefamulin

lefamulin acetate

Centralised EU authorisationActive

Marketing holder: Venipharm

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • Xenleta
    TABLET, COATED · LEFAMULIN ACETATE 600 mg/1
    71288-037
    Meitheal Pharmaceuticals Inc.
  • Xenleta
    INJECTION, SOLUTION · LEFAMULIN ACETATE 150 mg/15mL
    71288-039
    Meitheal Pharmaceuticals Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-c2e8-74fc-9604-b00eeed8c3b2,01a12097-2429-7605-8f62-d558738fad5f;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005048
Registration status
Active
ATC code
J01XX
Sources
  • product · EMA · EMEA/H/C/005048 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005048 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005048 · Verified 2026-10-09