🇪🇺 Caprelsa in European Union

EMA authorised Caprelsa on 16 February 2012

Marketing authorisation

EMA — authorised 16 February 2012

  • Application: EMEA/H/C/002315
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Caprelsa
  • Indication: Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
  • Status: approved

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Caprelsa in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is Caprelsa approved in European Union?

Yes. EMA authorised it on 16 February 2012.

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

Sanofi B.V. holds the EU marketing authorisation.