🇪🇺 clofarabine (IV formulation) in European Union

EMA authorised clofarabine (IV formulation) on 29 May 2006

Marketing authorisation

EMA — authorised 29 May 2006

  • Application: EMEA/H/C/000613
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Evoltra
  • Indication: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.
  • Pathway: exceptional circumstances
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is clofarabine (IV formulation) approved in European Union?

Yes. EMA authorised it on 29 May 2006.

Who is the marketing authorisation holder for clofarabine (IV formulation) in European Union?

Sanofi B.V. holds the EU marketing authorisation.