🇪🇺 Xolremdi in European Union

EMA authorised Xolremdi on 27 April 2026

Marketing authorisation

EMA — authorised 27 April 2026

  • Application: EMEA/H/C/006496
  • Marketing authorisation holder: X4 Pharmaceuticals GmbH
  • Local brand name: Xolremdi
  • Indication: Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
  • Pathway: exceptional circumstances, orphan
  • Status: approved

The European Medicines Agency (EMA) approved Xolremdi for the treatment of WHIM syndrome in patients aged 12 years and older. WHIM syndrome is a rare condition characterised by warts, low levels of antibodies, frequent infections, and a reduction in neutrophils and lymphocytes. Xolremdi, developed by X4 Pharmaceuticals GmbH, aims to increase the number of circulating mature neutrophils and lymphocytes in these patients.

Read official source →

Xolremdi in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Xolremdi approved in European Union?

Yes. EMA authorised it on 27 April 2026.

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

X4 Pharmaceuticals GmbH holds the EU marketing authorisation.