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Besremi

Active substance: ropeginterferon alfa-2b

ropeginterferon alfa-2b

Centralised EU authorisationActive

Marketing holder: AOP Orphan Pharmaceuticals GmbH

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
  • BESREMi
    INJECTION · ROPEGINTERFERON ALFA-2B 500 ug/mL
    73536-500
    PharmaEssentia USA
  • BESREMi Pen
    INJECTION, SOLUTION · ROPEGINTERFERON ALFA-2B 500 ug/.5mL
    73536-511
    PharmaEssentia USA
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2ee9-7a75-a790-ad529013ff4a,01a1208c-2eea-77cc-9038-35d723b3b0d8;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004128
Registration status
Active
ATC code
L03AB15
Sources
  • product · EMA · EMEA/H/C/004128 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004128 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004128 · Verified 2026-10-09