🇪🇺 BMN 111 in European Union

EMA authorised BMN 111 on 26 August 2021

Marketing authorisation

EMA — authorised 26 August 2021

  • Application: EMEA/H/C/005475
  • Marketing authorisation holder: BioMarin International Limited
  • Local brand name: Voxzogo
  • Indication: Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
  • Pathway: orphan
  • Status: approved

Read official source →

Frequently asked questions

Is BMN 111 approved in European Union?

Yes. EMA authorised it on 26 August 2021.

Who is the marketing authorisation holder for BMN 111 in European Union?

BioMarin International Limited holds the EU marketing authorisation.