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Miplyffa

Active substance: Arimoclomol

arimoclomol citrate

Centralised EU authorisationActive

Marketing holder: Orphazyme A/S

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 4
  • MIPLYFFA
    CAPSULE · ARIMOCLOMOL CITRATE 124 mg/1
    72542-124
    Acer Therapeutics Inc.
  • MIPLYFFA
    CAPSULE · ARIMOCLOMOL CITRATE 47 mg/1
    72542-147
    Acer Therapeutics Inc.
  • MIPLYFFA
    CAPSULE · ARIMOCLOMOL CITRATE 93 mg/1
    72542-193
    Acer Therapeutics Inc.
  • MIPLYFFA
    CAPSULE · ARIMOCLOMOL CITRATE 62 mg/1
    72542-162
    Acer Therapeutics Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-e34d-7389-8859-8f2ec7ce67eb,01a12090-e351-7768-a0dc-875303a9814b,01a12092-ab70-774f-ba77-cc85b688f0c2,01a12095-17e7-72b7-a9be-4f26690b687a;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005203
Registration status
Active
ATC code
N07
Sources
  • product · EMA · EMEA/H/C/005203 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005203 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005203 · Verified 2026-10-09