🇪🇺 Pentosan polysulfate sodium 100 mg in European Union

EMA authorised Pentosan polysulfate sodium 100 mg on 2 June 2017

Marketing authorisation

EMA — authorised 2 June 2017

  • Application: EMEA/H/C/004246
  • Marketing authorisation holder: bene-Arzneimittel GmbH
  • Local brand name: Elmiron
  • Indication: Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.
  • Status: approved

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Pentosan polysulfate sodium 100 mg in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Pentosan polysulfate sodium 100 mg approved in European Union?

Yes. EMA authorised it on 2 June 2017.

Who is the marketing authorisation holder for Pentosan polysulfate sodium 100 mg in European Union?

bene-Arzneimittel GmbH holds the EU marketing authorisation.