🇪🇺 Cystadane in European Union

EMA authorised Cystadane on 14 February 2007

Marketing authorisation

EMA — authorised 14 February 2007

  • Application: EMEA/H/C/000678
  • Marketing authorisation holder: Recordati Rare Diseases
  • Local brand name: Cystadane
  • Indication: Adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS); 5,10-methylene-tetrahydrofolate reductase (MTHFR); cobalamin cofactor metabolism (cbl). Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
  • Status: approved

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Cystadane in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Cystadane approved in European Union?

Yes. EMA authorised it on 14 February 2007.

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

Recordati Rare Diseases holds the EU marketing authorisation.