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Xydalba

Active substance: dalbavancin

dalbavancin hydrochloride

Centralised EU authorisationActive

Marketing holder: AbbVie Deutschland GmbH & Co. KG

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
RU 1
  • Ксидалба
    лиофилизат для приготовления концентрата для приготовления раствора для инфузий, 500 мг, (original in Russian, GRLS)
    ЛП-004255
    Азиенде Кимике Риуните Анжелини Франческо А.К.Р.А.Ф. С.п.А.
US 7
  • DALBAVANCIN HYDROCHLORIDE
    INJECTION, POWDER, FOR SOLUTION · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
    65219-120
    Fresenius Kabi USA, LLC
  • DALVANCE
    INJECTION, POWDER, FOR SOLUTION · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
    57970-100
    Allergan, Inc.
  • Dalbavancin
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
    71288-034
    Meitheal Pharmaceuticals Inc
  • Dalbavancin
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
    71839-144
    BE Pharmaceuticals Inc.
  • Dalbavancin
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
    70069-830
    Somerset Therapeutics, LLC
All products in this country (7)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c4-b959-799d-bd9e-21ab5521256b;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a12091-ed18-727b-963e-01d8cab8e9f7,01a12092-8e6b-73ae-a4e9-563caa88f6cb,01a12092-9c23-7680-a864-33866e296665,01a12094-b5a7-7a6e-9ca7-564ca7bd0e4c,01a1209a-1fe9-7157-aa4a-66a74239bd32;count=7 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002840
Registration status
Active
ATC code
J01XA04
Sources
  • product · EMA · EMEA/H/C/002840 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002840 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002840 · Verified 2026-10-09