🇪🇺 EPYSQLI in European Union

EMA authorised EPYSQLI on 26 May 2023

Marketing authorisation

EMA — authorised 26 May 2023

  • Application: EMEA/H/C/006036
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Epysqli
  • Indication: Epysqli is indicated in adults and children for the treatment of:- Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.- Atypical haemolytic uremic syndrome (aHUS).
  • Pathway: biosimilar
  • Status: approved

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EPYSQLI in other countries

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

Other Other approved in European Union

Frequently asked questions

Is EPYSQLI approved in European Union?

Yes. EMA authorised it on 26 May 2023.

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

Samsung Bioepis NL B.V. holds the EU marketing authorisation.