🇪🇺 KYMRIAH in European Union

EMA authorised KYMRIAH on 23 August 2018

Marketing authorisation

EMA — authorised 23 August 2018

  • Application: EMEA/H/C/004090
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Kymriah
  • Indication: Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Pathway: orphan, ATMP, PRIME
  • Status: approved

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KYMRIAH 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 KYMRIAH approved in European Union?

Yes. EMA authorised it on 23 August 2018.

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

Novartis Europharm Limited holds the EU marketing authorisation.