🇪🇺 reteplase 10+10 U in European Union

EMA authorised reteplase 10+10 U on 29 August 1996

Marketing authorisation

EMA — authorised 29 August 1996

  • Application: EMEA/H/C/000105
  • Marketing authorisation holder: Actavis Group PTC ehf
  • Local brand name: Rapilysin
  • Indication: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.
  • Status: withdrawn

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Other Cardiovascular approved in European Union

Frequently asked questions

Is reteplase 10+10 U approved in European Union?

Yes. EMA authorised it on 29 August 1996.

Who is the marketing authorisation holder for reteplase 10+10 U in European Union?

Actavis Group PTC ehf holds the EU marketing authorisation.