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Abiraterone Mylan

Active substance: abiraterone

abiraterone acetate

Centralised EU authorisationActive

Marketing holder: Mylan Pharmaceuticals 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 45
  • ABIRATERONE ACETATE
    TABLET · ABIRATERONE ACETATE 500 mg/1
    42291-073
    AvKARE
  • ABIRATERONE ACETATE
    TABLET · ABIRATERONE ACETATE 125 mg/1
    51407-503
    Golden State Medical Supply, Inc.
  • ABIRATERONE ACETATE
    TABLET · ABIRATERONE ACETATE 500 mg/1
    69238-1754
    Amneal Pharmaceuticals NY LLC
  • ABIRATERONE ACETATE
    TABLET · ABIRATERONE ACETATE 500 mg/1
    60219-1754
    Amneal Pharmaceuticals LLC
  • AKEEGA
    TABLET, FILM COATED · NIRAPARIB TOSYLATE MONOHYDRATE 100 mg/1, ABIRATERONE ACETATE 500 mg/1
    57894-100
    Janssen Biotech, Inc.
All products in this country (45)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-59a4-7772-af69-ceee0232dfe7,01a1208c-83df-7d9d-bf80-d4cfa5708e84,01a1208c-da0d-7232-825f-74703b914aa1,01a1208c-da0e-7c19-b9d5-697b5a74aaea,01a1208c-f279-7c9f-94ed-04becf225d24;count=43 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005368
Registration status
Active
ATC code
L02BX03
Sources
  • product · EMA · EMEA/H/C/005368 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005368 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005368 · Verified 2026-10-09