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Koselugo

Active substance: selumetinib

selumetinib sulfate

Centralised EU authorisationActive

Marketing holder: AstraZeneca AB

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
  • KOSELUGO
    CAPSULE · SELUMETINIB 25 mg/1
    0310-0625
    AstraZeneca Pharmaceuticals LP
  • KOSELUGO
    GRANULE · SELUMETINIB 7.5 mg/1
    0310-0640
    AstraZeneca Pharmaceuticals LP
  • KOSELUGO
    CAPSULE · SELUMETINIB 10 mg/1
    0310-0610
    AstraZeneca Pharmaceuticals LP
  • KOSELUGO
    GRANULE · SELUMETINIB 5 mg/1
    0310-0635
    AstraZeneca Pharmaceuticals LP
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-7816-7a21-b07c-09b75477ec00,01a1209b-8aa7-736f-9742-963ede98a03f,01a1209d-d791-7f32-a262-1e290369aa5a,01a1209d-d797-7184-a836-7e1785046ec1;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005244
Registration status
Active
ATC code
L01EE04
Sources
  • product · EMA · EMEA/H/C/005244 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005244 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005244 · Verified 2026-10-09