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Fingolimod Mylan

Active substance: fingolimod

fingolimod hydrochloride 

Centralised EU authorisationActive

Marketing holder: Mylan Ireland Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
  • fingolimod hydrochloride 
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
RU 25
  • Гилениа®
    капсулы, 0.5 мг (original in Russian, GRLS)
    ЛСР-008272/10
    Новартис Фарма АГ
  • Лифеспан®
    капсулы, 0.5 мг (original in Russian, GRLS)
    ЛП-006546
    Акционерное общество "Валента Фармацевтика" (АО "Валента Фарм")
  • Лифеспан®
    таблетки, 0.5 мг (original in Russian, GRLS)
    ЛП-№(004423)-(РГ-RU)
    Акционерное общество "Валента Фармацевтика" (АО "Валента Фарм")
  • Лифеспан®
    капсулы, 0.5 мг (original in Russian, GRLS)
    ЛП-№(005894)-(РГ-RU)
    Акционерное общество "Валента Фармацевтика" (АО "Валента Фарм")
  • Лифеспан®
    таблетки, 0.5 мг (original in Russian, GRLS)
    ЛП-005378
    Акционерное общество "Валента Фармацевтика" (АО "Валента Фарм")
All products in this country (25)
US 24
  • FINGOLIMOD
    CAPSULE · FINGOLIMOD .5 mg/1
    43547-003
    Solco Healthcare US, LLC
  • FINGOLIMOD
    CAPSULE · FINGOLIMOD HYDROCHLORIDE .5 mg/1
    82009-143
    Quallent Pharmaceuticals Health LLC
  • FINGOLIMOD
    CAPSULE · FINGOLIMOD HYDROCHLORIDE .5 mg/1
    70377-019
    Biocon Pharma Inc.
  • FINGOLIMOD
    CAPSULE · FINGOLIMOD HYDROCHLORIDE .5 mg/1
    65862-952
    Aurobindo Pharma Limited
  • FINGOLIMOD HYDROCHLORIDE
    CAPSULE · FINGOLIMOD HYDROCHLORIDE .5 mg/1
    16729-342
    Accord Healthcare Inc.
All products in this country (24)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-31a4-7911-99c2-9444dc2be8ee,01a120c3-3b48-7d93-aa18-60916c3e52fc,01a120c3-5c0d-7216-8e42-4ef97a181668,01a120c3-5e2c-7ce9-98ce-551d3fdc7b5c,01a120c3-60d0-7d51-a1b0-93bd117b4fd5;count=18 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-5dc0-7d0a-8aa1-6bd469ab75a4,01a1208c-bc9a-77d1-ade0-bff56ece2e1f,01a1208c-fab8-70dd-9760-e7e079af0f37,01a1208d-5fe5-7f8d-ae57-b88ee7a528f0,01a1208d-cd41-77de-ba4c-743d2da87dd2;count=24 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005282
Registration status
Active
ATC code
L04AA27
Sources
  • product · EMA · EMEA/H/C/005282 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005282 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005282 · Verified 2026-10-09