🇪🇺 GS010 in European Union

GS010 (GS010) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/005047
  • Marketing authorisation holder: GenSight Biologics S.A.
  • Local brand name: Lumevoq
  • Indication: Lumevoq (lenadogene nolparvovec) is indicated for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by a confirmed G11778A mutation in the ND4 mitochondrial gene (see section 5.1).
  • Pathway: orphan
  • Status: withdrawn

Read official source →

Frequently asked questions

Is GS010 approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for GS010 in European Union?

GenSight Biologics S.A. holds the EU marketing authorisation.