🇪🇺 KPL-914 in European Union

EMA authorised KPL-914 on 23 October 2009

Marketing authorisations

EMA — authorised 23 October 2009

  • Application: EMEA/H/C/001047
  • Marketing authorisation holder: Regeneron UK Limited
  • Local brand name: Rilonacept Regeneron (previously Arcalyst)
  • Indication: Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.
  • Pathway: exceptional circumstances
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/006537
  • Marketing authorisation holder: Rilonacept FGK Representative Service GmbH
  • Local brand name: Rilonacept FGK Representative Service GmbH
  • Indication: Treatment of idiopathic pericarditis 
  • Pathway: orphan
  • Status: withdrawn

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Frequently asked questions

Is KPL-914 approved in European Union?

Yes. EMA authorised it on 23 October 2009; EMA has authorised it.

Who is the marketing authorisation holder for KPL-914 in European Union?

Regeneron UK Limited holds the EU marketing authorisation.