🇪🇺 Ilaris® in European Union

EMA authorised Ilaris® on 23 October 2009

Marketing authorisations

EMA — authorised 23 October 2009

  • Application: EMEA/H/C/001109
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Ilaris
  • Indication: Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and
  • Status: approved

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EMA

  • Application: EMEA/H/C/004754
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Canakinumab Novartis
  • Indication: Prevention of major cardiovascular events
  • Status: withdrawn

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Ilaris® 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 Ilaris® approved in European Union?

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

Who is the marketing authorisation holder for Ilaris® in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.