🇪🇺 Nulibry in European Union

EMA authorised Nulibry on 15 September 2022

Marketing authorisations

EMA — authorised 15 September 2022

  • Marketing authorisation holder: COMHARSA LIFE SCIENCES LTD
  • Status: approved

EMA — authorised 15 September 2022

  • Application: EMEA/H/C/005378
  • Marketing authorisation holder: TMC Pharma (EU) Limited
  • Local brand name: Nulibry
  • Indication: NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.
  • Pathway: orphan
  • Status: approved

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Nulibry in other countries

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

Other Neuroscience approved in European Union

Frequently asked questions

Is Nulibry approved in European Union?

Yes. EMA authorised it on 15 September 2022; EMA authorised it on 15 September 2022.

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

COMHARSA LIFE SCIENCES LTD holds the EU marketing authorisation.