🇪🇺 MEPSEVII in European Union

EMA authorised MEPSEVII on 23 August 2018

Marketing authorisation

EMA — authorised 23 August 2018

  • Application: EMEA/H/C/004438
  • Marketing authorisation holder: Ultragenyx Germany GmbH
  • Local brand name: Mepsevii
  • Indication: Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
  • Pathway: exceptional circumstances, orphan
  • Status: approved

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MEPSEVII 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 MEPSEVII approved in European Union?

Yes. EMA authorised it on 23 August 2018.

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

Ultragenyx Germany GmbH holds the EU marketing authorisation.