🇪🇺 Cladribine Pill in European Union

EMA authorised Cladribine Pill on 22 August 2017

Marketing authorisation

EMA — authorised 22 August 2017

  • Application: EMEA/H/C/004230
  • Marketing authorisation holder: Merck Europe B.V.
  • Local brand name: Mavenclad
  • Indication: Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
  • Status: approved

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Frequently asked questions

Is Cladribine Pill approved in European Union?

Yes. EMA authorised it on 22 August 2017.

Who is the marketing authorisation holder for Cladribine Pill in European Union?

Merck Europe B.V. holds the EU marketing authorisation.