🇪🇺 Raplixa in European Union

EMA authorised Raplixa on 19 March 2015

Marketing authorisation

EMA — authorised 19 March 2015

  • Application: EMEA/H/C/002807
  • Marketing authorisation holder: Mallinckrodt Pharmaceuticals Ireland Limited
  • Local brand name: Raplixa
  • Indication: Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge. Raplixa is indicated in adults over 18 years of age.
  • Status: withdrawn

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Other Other approved in European Union

Frequently asked questions

Is Raplixa approved in European Union?

Yes. EMA authorised it on 19 March 2015.

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

Mallinckrodt Pharmaceuticals Ireland Limited holds the EU marketing authorisation.