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Exondys

Active substance: eteplirsen

eteplirsen

Centralised EU authorisationActive

Marketing holder: AVI Biopharma International Ltd

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 4
  • Exondys 51
    INJECTION · ETEPLIRSEN 50 mg/mL
    60923-284
    Sarepta Therapeutics, Inc.
  • Exondys 51
    INJECTION · ETEPLIRSEN 50 mg/mL
    60923-363
    Sarepta Therapeutics, Inc.
  • eteplirsen
    INJECTION · ETEPLIRSEN 100 mg/2mL
    61434-003
    Catalent Indiana, LLC
  • eteplirsen
    INJECTION · ETEPLIRSEN 500 mg/10mL
    61434-035
    Catalent Indiana, LLC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-5891-729b-90fd-87aa11428487,01a1208f-8219-7939-94d9-2819b76167e3,01a12092-09b9-72a2-8bae-69484981eef4,01a12095-6afc-7cfb-9550-dfc3cc855bf6;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004355
Registration status
Active
ATC code
M09AX
Sources
  • product · EMA · EMEA/H/C/004355 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004355 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004355 · Verified 2026-10-09