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Krystexxa

Active substance: pegloticase

pegloticase

Centralised EU authorisationWithdrawn

Marketing holder: Crealta Pharmaceuticals Ireland Limited

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
  • Krystexxa
    INJECTION, SOLUTION · PEGLOTICASE 8 mg/50mL
    75987-058
    Horizon Therapeutics USA, Inc.
  • Krystexxa
    INJECTION, SOLUTION · PEGLOTICASE 8 mg/mL
    75987-080
    Horizon Therapeutics USA, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3092-7be7-b03a-7f499b98acd9,01a12097-5aa9-79c6-83fe-cff174dfcaaa;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002208
Registration status
Withdrawn
ATC code
M04AX02
Sources
  • product · EMA · EMEA/H/C/002208 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002208 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002208 · Verified 2026-10-09