🇪🇺 Provayblue in European Union

EMA authorised Provayblue on 6 May 2011

Marketing authorisations

EMA — authorised 6 May 2011

  • Application: EMEA/H/C/002108
  • Marketing authorisation holder: Provepharm SAS
  • Local brand name: Methylthioninium chloride Proveblue
  • Indication: Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia. Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
  • Status: approved

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EMA — authorised 19 August 2020

  • Application: EMEA/H/C/002776
  • Marketing authorisation holder: Cosmo Technologies Ltd
  • Local brand name: Lumeblue (previously Methylthioninium chloride Cosmo)
  • Indication: Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
  • Status: approved

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Provayblue in other countries

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

Other Rare Disease approved in European Union

Frequently asked questions

Is Provayblue approved in European Union?

Yes. EMA authorised it on 6 May 2011; EMA authorised it on 19 August 2020.

Who is the marketing authorisation holder for Provayblue in European Union?

Provepharm SAS holds the EU marketing authorisation.