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Sarclisa

Active substance: isatuximab

INJECTION, SOLUTION, CONCENTRATE · ISATUXIMAB 500 mg/25mL

United StatesActive

Marketing holder: Sanofi-Aventis U.S. 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 2
  • Сарклиза®
    концентрат для приготовления раствора для инфузий, 20 мг/мл, 25 мл (original in Russian, GRLS)
    ЛП-№(001362)-(РГ-RU)
    Санофи Винтроп Индустрия
  • Сарклиза®
    концентрат для приготовления раствора для инфузий, 20 мг/мл, 25 мл (original in Russian, GRLS)
    ЛП-006430
    АО "Санофи-авентис груп"
EU 1
  • Sarclisa
    Isatuximab
    EMEA/H/C/004977
    Sanofi Winthrop Industrie
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-3efa-7271-bac3-597027466672,01a120c5-e21f-7072-b2b1-2466086fdf48;count=2 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-7cd8-75ce-94c4-d0b8f2dd448f,01a1208f-f004-7280-87f6-1e7e393d398a,01a12093-c85d-7945-87fb-ffcdb36f8cff;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0024-0656
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 0024-0656 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0024-0656 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0024-0656 · Verified 2026-10-09 · open in source