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FINGOLIMOD

Active substance: fingolimod

CAPSULE · FINGOLIMOD HYDROCHLORIDE .5 mg/1

United StatesActive

Marketing holder: Quallent Pharmaceuticals Health LLC

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
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)
EU 4
  • Fingolimod Accord
    fingolimod hydrochloride 
    EMEA/H/C/005191
    Accord Healthcare S.L.U.
  • Fingolimod Mylan
    Fingolimod
    EMEA/H/C/005661
    Mylan Pharmaceuticals Limited
  • Fingolimod Mylan
    fingolimod hydrochloride 
    EMEA/H/C/005282
    Mylan Ireland Limited
  • Gilenya
    fingolimod hydrochloride 
    EMEA/H/C/002202
    Novartis Europharm Limited
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
82009-143
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 82009-143 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 82009-143 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 82009-143 · Verified 2026-10-09 · open in source