🇪🇺 RYSTIGGO in European Union

EMA authorised RYSTIGGO on 5 January 2024

Marketing authorisation

EMA — authorised 5 January 2024

  • Application: EMEA/H/C/005824
  • Marketing authorisation holder: UCB Pharma
  • Local brand name: Rystiggo
  • Indication: Rystiggo 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) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
  • Pathway: orphan
  • Status: approved

The European Medicines Agency (EMA) has approved Rystiggo, a treatment for generalised myasthenia gravis (gMG) in adult patients. Rystiggo is indicated as an add-on to standard therapy for patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. This approval was granted under the orphan designation, which is reserved for medicines treating rare diseases.

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RYSTIGGO 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 RYSTIGGO approved in European Union?

Yes. EMA authorised it on 5 January 2024.

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

UCB Pharma holds the EU marketing authorisation.