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Mylotarg

Active substance: gemtuzumab ozogamicin

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · GEMTUZUMAB OZOGAMICIN 5 mg/5mL

United StatesActive

Marketing holder: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

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
  • Милотарг®
    лиофилизат для приготовления концентрата для приготовления раствора для инфузий, 5 мг, 5 мг (original in Russian, GRLS)
    ЛП-№(008765)-(РГ-RU)
    Пфайзер Инк
  • Милотарг®
    лиофилизат для приготовления концентрата для приготовления раствора для инфузий, 5 мг, 5 мг (original in Russian, GRLS)
    ЛП-008678
    Пфайзер Инк.
EU 2
  • Mylotarg
    gemtuzumab ozogamicin
    EMEA/H/C/004204
    Pfizer Europe MA EEIG
  • Mylotarg
    gemtuzumab ozogamicin
    EMEA/H/C/000705
    Wyeth Europa Ltd
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-9b50-7ade-9ba9-7b991d6e3c8e,01a120c6-1c9d-7761-bab5-2f82cfe95195;count=2 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a12095-c834-7bb8-bf74-d8bdc37ecc22;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0008-4510
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 0008-4510 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0008-4510 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0008-4510 · Verified 2026-10-09 · open in source