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Colobreathe

Active substance: colistimethate

Colistimethate sodium

Centralised EU authorisationActive

Marketing holder: Essential Pharma Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 5
  • COLISTIMETHATE SODIUM
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · COLISTIMETHATE SODIUM 150 mg/4mL
    23155-193
    Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
  • Colistimethate
    INJECTION, POWDER, FOR SOLUTION · COLISTIMETHATE SODIUM 150 mg/1
    70594-023
    Xellia Pharmaceuticals USA LLC
  • Colistimethate
    INJECTION, POWDER, FOR SOLUTION · COLISTIMETHATE SODIUM 150 mg/1
    0143-9443
    Hikma Pharmaceuticals USA Inc.
  • Colistimethate
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · COLISTIMETHATE SODIUM 150 mg/2mL
    63323-393
    Fresenius Kabi USA, LLC
  • Coly-Mycin M
    INJECTION · COLISTIMETHATE SODIUM 150 mg/2mL
    42023-107
    Par Health USA, LLC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-ddb3-71ff-a1d4-08e138b54704,01a1208f-a5e6-724c-8aeb-f9ad0347b6e7,01a12092-2c85-75f3-8291-bbf29d426094,01a12093-65b9-74b9-a506-2f26e1eec15c,01a12098-07f1-7bea-9fa0-900399376bb9;count=5 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/001225
Registration status
Active
ATC code
J01XB01
Sources
  • product · EMA · EMEA/H/C/001225 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/001225 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/001225 · Verified 2026-10-09