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Daliresp

Active substance: roflumilast

roflumilast

Centralised EU authorisationWithdrawn

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
RU 1
  • Даксас
    таблетки покрытые пленочной оболочкой, 0.5 мг (original in Russian, GRLS)
    ЛП-000573
    АстраЗенека АБ
US 33
  • Daliresp
    TABLET · ROFLUMILAST 250 ug/1
    0310-0088
    AstraZeneca Pharmaceuticals LP
  • Daliresp
    TABLET · ROFLUMILAST 500 ug/1
    0310-0095
    AstraZeneca Pharmaceuticals LP
  • ROFLUMILAST
    TABLET · ROFLUMILAST 500 ug/1
    59651-275
    Aurobindo Pharma Limited
  • ROFLUMILAST
    TABLET · ROFLUMILAST 250 ug/1
    42571-369
    Micro Labs Limited
  • ROFLUMILAST
    TABLET · ROFLUMILAST 500 ug/1
    42571-259
    Micro Labs Limited
All products in this country (33)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c5-0088-7dc0-9963-7afbcab3ab13;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-949a-7954-af4c-2b433822f0ad,01a1208c-c907-707d-a584-e4b8f4c0ba3f,01a1208c-f534-78cc-98e3-aa5300dfccfa,01a1208c-f54f-7964-af58-a9487b00fea1,01a1208d-51ef-7ece-ae17-3cec2c718d8f;count=33 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002398
Registration status
Withdrawn
ATC code
R03DX07
Sources
  • product · EMA · EMEA/H/C/002398 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002398 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002398 · Verified 2026-10-09