🇪🇺 EYDENZELT in European Union

EMA authorised EYDENZELT on 12 February 2025

Marketing authorisation

EMA — authorised 12 February 2025

  • Application: EMEA/H/C/005899
  • Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
  • Local brand name: Eydenzelt
  • Indication: Eydenzelt is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
  • Pathway: biosimilar
  • Status: approved

The European Medicines Agency (EMA) approved EYDENZELT, a biosimilar, for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation. This approval was granted on 12 February 2025. EYDENZELT is manufactured by Celltrion Healthcare Hungary Kft. and will be marketed under the local brand name Eydenzelt.

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EYDENZELT 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 EYDENZELT approved in European Union?

Yes. EMA authorised it on 12 February 2025.

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

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.