🇪🇺 YESAFILI in European Union

EMA authorised YESAFILI on 15 September 2023

Marketing authorisation

EMA — authorised 15 September 2023

  • Application: EMEA/H/C/006022
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Yesafili
  • Indication: Yesafili 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

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YESAFILI 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 YESAFILI approved in European Union?

Yes. EMA authorised it on 15 September 2023.

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

Biosimilar Collaborations Ireland Limited holds the EU marketing authorisation.