🇪🇺 Eculizumab Injection in European Union

EMA authorised Eculizumab Injection on 20 June 2007

Marketing authorisation

EMA — authorised 20 June 2007

  • Application: EMEA/H/C/000791
  • Marketing authorisation holder: Alexion Europe SAS
  • Local brand name: Soliris
  • Indication: Soliris 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 (see section 5.1).  Atypical haemolytic uremic syndrome (aHUS). Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Neuromyelitis optica spectrum disorder (NMOSD) in patie
  • Pathway: accelerated assessment, orphan
  • Status: approved

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Eculizumab Injection in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is Eculizumab Injection approved in European Union?

Yes. EMA authorised it on 20 June 2007.

Who is the marketing authorisation holder for Eculizumab Injection in European Union?

Alexion Europe SAS holds the EU marketing authorisation.