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Омализумаб

Active substance: omalizumab

субстанция-раствор, ~, 100 г (original in Russian, GRLS)

RussiaWithdrawn

Marketing holder: Акционерное общество "ГЕНЕРИУМ" (АО "ГЕНЕРИУМ")

Verified 2026-10-09 · GRLS (Russian state register)

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 11
  • OMLYCLO
    INJECTION · OMALIZUMAB 150 mg/mL
    72606-036
    CELLTRION USA, Inc.
  • OMLYCLO
    INJECTION · OMALIZUMAB 300 mg/2mL
    72606-054
    CELLTRION USA, Inc.
  • OMLYCLO
    INJECTION · OMALIZUMAB 75 mg/.5mL
    72606-035
    CELLTRION USA, Inc.
  • XOLAIR
    INJECTION, SOLUTION · OMALIZUMAB 150 mg/1.2mL
    50242-040
    Genentech, Inc.
  • Xolair
    INJECTION, SOLUTION · OMALIZUMAB 300 mg/2mL
    50242-227
    Genentech, Inc.
All products in this country (11)
EU 3
  • Adcomfo
    omalizumab
    EMEA/H/C/006756
    Advanz Pharma Limited
  • Omlyclo
    omalizumab
    EMEA/H/C/005958
    Celltrion Healthcare Hungary Kft.
  • Xolair
    omalizumab
    EMEA/H/C/000606
    Novartis Europharm Limited
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-54cf-79f9-86f9-b732d45e30ca,01a120c3-7e0c-7c41-af94-3feeb0d17808,01a120c3-db66-7c4b-a899-ece7f32f0a79,01a120c4-0a07-7d48-9840-d6b07c4f118d,01a120c5-bfd6-7083-b81f-5972735f2dcb;count=6 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2cde-7bde-9607-43e39367a42f,01a1208c-cc95-7f18-a29a-08946090a10f,01a1208d-f7de-777d-a915-a5c0048e9fae,01a12091-b66e-7893-a58d-4dd7c8035971,01a12095-66b0-74cb-b854-d0a321cb8025;count=11 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
ФС-002052
Registration status
Withdrawn
Release forms
субстанция-раствор, ~, 100 г - контейнеры полимерные - Не указано; show all (7)субстанция-раствор, ~, 100 г - контейнеры полимерные - Не указано; субстанция-раствор, ~, 50 г - контейнеры полимерные - Не указано; субстанция-раствор, ~, 50 кг - контейнеры полимерные - Не указано; субстанция-раствор, ~, 20 кг - контейнеры полимерные - Не указано; субстанция-раствор, ~, 10 кг - контейнеры полимерные - Не указано; субстанция-раствор, ~, 5 кг - контейнеры полимерные - Не указано; субстанция-раствор, ~, 1 кг - контейнеры полимерные - Не указано;
(original in Russian, GRLS)
Sources
  • product · GRLS (Russian state register) · ФС-002052 · Verified 2026-10-09
  • registration_status · GRLS (Russian state register) · ФС-002052 · Verified 2026-10-09
  • ingredients.0 · GRLS (Russian state register) · ФС-002052 · Verified 2026-10-09