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Dimethyl fumarate Mylan

Active substance: dimethyl fumarate

dimethyl fumarate

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
RU 15
  • ДИМЕТИЛФУМАРАТ
    субстанция-порошок, ~, 500 г (original in Russian, GRLS)
    ФС-002109
    ООО "Фарм-Синтез"
  • ДИМЕТИЛФУМАРАТ-ТЛ
    капсулы кишечнорастворимые, 240 мг (original in Russian, GRLS)
    ЛП-№(006453)-(РГ-RU)
    Общество с ограниченной ответственностью "Технология лекарств" (ООО "Технология лекарств")
  • Диметилфумарат
    капсулы кишечнорастворимые, 240 мг (original in Russian, GRLS)
    ЛП-№(009164)-(РГ-RU)
    Общество с ограниченной ответственностью "Атолл" (ООО "Атолл")
  • Диметилфумарат
    капсулы кишечнорастворимые, 240 мг (original in Russian, GRLS)
    ЛП-№(012001)-(РГ-RU)
    Хетеро Лабс Лимитед
  • Диметилфумарат
    субстанция-порошок, ~, 15 кг (original in Russian, GRLS)
    ФС-001559
    ПАО "Биосинтез"
All products in this country (15)
US 48
  • DIMETHYL FUMARATE
    CAPSULE, DELAYED RELEASE · DIMETHYL FUMARATE 240 mg/1
    82009-138
    Quallent Pharmaceuticals Health LLC
  • DIMETHYL FUMARATE
    CAPSULE, DELAYED RELEASE · DIMETHYL FUMARATE 240 mg/1
    16729-417
    Accord Healthcare Inc.
  • DIMETHYL FUMARATE
    CAPSULE · DIMETHYL FUMARATE 120 mg/1
    68462-307
    Glenmark Pharmaceuticals Inc., USA
  • DIMETHYL FUMARATE
    CAPSULE, DELAYED RELEASE · DIMETHYL FUMARATE 120 mg/1
    16729-416
    Accord Healthcare Inc.
  • DIMETHYL FUMARATE
    CAPSULE, DELAYED RELEASE · DIMETHYL FUMARATE 120 mg/1
    31722-657
    Camber Pharmaceuticals, Inc.
All products in this country (48)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-3188-7aab-b315-aa8ac40c6095,01a120c3-54b0-77d9-bbf4-6b2db5f78eba,01a120c3-5c4b-792a-8773-1d1bff9f7970,01a120c3-5ea2-70a3-82d3-bc77861fd138,01a120c3-7b6f-7cb5-9996-d1ddae9de92d;count=13 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-367b-7f70-8e71-a8c49dd3edb4,01a1208c-4b05-703b-bbd2-9145bab6073c,01a1208c-51b9-710d-8264-ed7f32c7b1f8,01a1208c-9594-70f0-845e-5d65f6251721,01a1208c-a6d2-7b47-bc79-05faafd2adfe;count=48 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006397
Registration status
Active
ATC code
L04AX07
Sources
  • product · EMA · EMEA/H/C/006397 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006397 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006397 · Verified 2026-10-09