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KESIMPTA

Active substance: ofatumumab

INJECTION, SOLUTION · OFATUMUMAB 20 mg/.4mL

United StatesActive

Marketing holder: Novartis Pharmaceuticals Corporation

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
  • Бонспри®
    раствор для подкожного введения, 20 мг, 0.4 мл (original in Russian, GRLS)
    ЛП-№(001332)-(РГ-RU)
    Новартис Оверсиз Инвестментс АГ
  • Арзерра®
    концентрат для приготовления раствора для инфузий, 20 мг/мл, 50 мл (original in Russian, GRLS)
    ЛП-001550
    ЗАО "ГлаксоСмитКляйн Трейдинг"
EU 2
  • Kesimpta
    ofatumumab
    EMEA/H/C/005410
    Novartis Europharm Limited
  • Arzerra
    ofatumumab
    EMEA/H/C/001131
    Novartis Europharm Ltd
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-3ecd-7542-a898-23d52406cade,01a120c4-b4cb-771b-84fc-bf10a110e44e;count=2 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a12091-6cd9-737f-a31d-53b0f606dfdc;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0078-1007
Registration status
Active
Dispensing
Prescription only
Route
SUBCUTANEOUS
Sources
  • product · openFDA NDC · 0078-1007 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0078-1007 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0078-1007 · Verified 2026-10-09 · open in source