🇪🇺 intravitreous aflibercept in European Union

EMA authorised intravitreous aflibercept on 21 November 2012

Marketing authorisation

EMA — authorised 21 November 2012

  • Application: EMEA/H/C/002392
  • Marketing authorisation holder: Bayer AG
  • Local brand name: Eylea
  • Indication: Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular o
  • Status: approved

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intravitreous aflibercept in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is intravitreous aflibercept approved in European Union?

Yes. EMA authorised it on 21 November 2012.

Who is the marketing authorisation holder for intravitreous aflibercept in European Union?

Bayer AG holds the EU marketing authorisation.