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Copiktra

Active substance: duvelisib

duvelisib

Centralised EU authorisationWithdrawn

Marketing holder: Secura Bio 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
RU 1
  • Копиктра®
    капсулы, 15 мг (original in Russian, GRLS)
    ЛП-006862
    АО "Санофи Россия"
US 2
  • COPIKTRA
    CAPSULE · DUVELISIB 25 mg/1
    73116-225
    Secura Bio, Inc
  • COPIKTRA
    CAPSULE · DUVELISIB 15 mg/1
    73116-215
    Secura Bio, Inc
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c4-ba77-7502-995b-fa2274d7e64a;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-be59-7e83-9789-089da06614af,01a12097-4eef-7c2d-95e4-5de287677a5b;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005381
Registration status
Withdrawn
ATC code
L01EM04
Sources
  • product · EMA · EMEA/H/C/005381 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005381 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005381 · Verified 2026-10-09