🇪🇺 AAV2-hRPE65v2,voretigene neparvovec-rzyl in European Union

EMA authorised AAV2-hRPE65v2,voretigene neparvovec-rzyl on 22 November 2018

Marketing authorisation

EMA — authorised 22 November 2018

  • Application: EMEA/H/C/004451
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Luxturna
  • Indication: Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
  • Pathway: orphan, ATMP
  • Status: approved

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Other Ophthalmology approved in European Union

Frequently asked questions

Is AAV2-hRPE65v2,voretigene neparvovec-rzyl approved in European Union?

Yes. EMA authorised it on 22 November 2018.

Who is the marketing authorisation holder for AAV2-hRPE65v2,voretigene neparvovec-rzyl in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.