🇪🇺 Cystagon in European Union

EMA authorised Cystagon on 23 June 1997

Marketing authorisation

EMA — authorised 23 June 1997

  • Application: EMEA/H/C/000125
  • Marketing authorisation holder: Recordati Rare Diseases
  • Local brand name: Cystagon
  • Indication: Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
  • Status: approved

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Cystagon in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Cystagon approved in European Union?

Yes. EMA authorised it on 23 June 1997.

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

Recordati Rare Diseases holds the EU marketing authorisation.