🇪🇺 Zilbrysq in European Union

EMA authorised Zilbrysq on 1 December 2023

Marketing authorisation

EMA — authorised 1 December 2023

  • Application: EMEA/H/C/005450
  • Marketing authorisation holder: UCB Pharma S.A.
  • Local brand name: Zilbrysq
  • Indication: Zilbrysq is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
  • Status: approved

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Zilbrysq 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 Zilbrysq approved in European Union?

Yes. EMA authorised it on 1 December 2023.

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

UCB Pharma S.A. holds the EU marketing authorisation.