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Sirolimus

Active substance: sirolimus

SOLUTION · SIROLIMUS 1 mg/mL

United StatesActive

Marketing holder: Amneal Pharmaceuticals NY 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 5
  • Рапамун®
    таблетки, покрытые оболочкой, 1 мг (original in Russian, GRLS)
    ЛП-№(012960)-(РГ-RU)
    Пфайзер Инк
  • Рапамун®
    раствор для приема внутрь, 1 мг/мл, 60 мл (original in Russian, GRLS)
    ЛП-№(013918)-(РГ-RU)
    Пфайзер Инк
  • Рапамун®
    таблетки, покрытые оболочкой, 1 мг (original in Russian, GRLS)
    ЛСР-002186/09
    Пфайзер Инк
  • Рапамун®
    раствор для приема внутрь, 1 мг/мл, 60 мл (original in Russian, GRLS)
    П N013700/01
    Пфайзер Инк
  • Сиролимус
    субстанция-порошок, ~, 1.1 кг (original in Russian, GRLS)
    ФС-002464
    Конкорд Биотек Лтд
EU 3
  • Hyftor
    sirolimus
    EMEA/H/C/005896
    Plusultra pharma GmbH
  • Opsiria
    sirolimus
    EMEA/H/C/003978
    Santen Oy
  • Rapamune
    sirolimus
    EMEA/H/C/000273
    Pfizer Europe MA EEIG
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-d17e-7016-b64d-884b86e97f7a,01a120c3-daf1-7094-bce2-64d0d3745820,01a120c6-4cfd-717b-9e3c-8b590d4ab834,01a120c6-84c1-7cbb-993e-ebf349611da9;count=4 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2f11-7c1b-a72f-44533bc85422,01a1208c-ac9c-7d3e-8a87-99c18331a987,01a1208d-8db6-7aa4-a66b-0f225af0d48f,01a1208d-8eef-701b-9e60-7cc82b9002d8,01a1208d-cbef-7244-b070-c5a953411da8;count=39 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
69238-1594
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 69238-1594 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 69238-1594 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 69238-1594 · Verified 2026-10-09 · open in source