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Elmiron

Active substance: pentosan polysulfate

pentosan polysulfate sodium

Centralised EU authorisationActive

Marketing holder: bene-Arzneimittel GmbH

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 1
  • ELMIRON
    CAPSULE, GELATIN COATED · PENTOSAN POLYSULFATE SODIUM 100 mg/1
    50458-098
    Janssen Pharmaceuticals, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-614b-754a-8e4a-9f522a29a370;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004246
Registration status
Active
ATC code
G04BX15
Sources
  • product · EMA · EMEA/H/C/004246 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004246 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004246 · Verified 2026-10-09