🇪🇺 Kesimpta in European Union

EMA authorised Kesimpta on 26 March 2021

Marketing authorisations

EMA — authorised 26 March 2021

  • Application: EMEA/H/C/005410
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Kesimpta
  • Indication: Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
  • Status: approved

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EMA

  • Local brand name: Kesimpta
  • Status: approved

Kesimpta in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is Kesimpta approved in European Union?

Yes. EMA authorised it on 26 March 2021; EMA has authorised it.

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

Novartis Europharm Limited holds the EU marketing authorisation.