Rexatilux (ranibizumab)
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Intas Third Party Sales 2005 S.L.
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration
- CHMP opinion
- Thu 23 Apr 2026
- EU approval
- Fri 19 Jun 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006634
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Rexatilux is indicated in adults for: - The treatment of neovascular (wet) age-related macular degeneration (AMD) - The treatment of visual impairment due to diabetic macular oedema (DME) - The treatment of proliferative diabetic retinopathy (PDR) - The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) - The treatment of visual impairment due to choroidal neovascularisation (CNV).
Regulatory milestones
Rexatilux (ranibizumab) approved in the EU
Marketing authorisation to Intas Third Party Sales 2005 S.L.; Biosimilar, Additional monitoring · source
Rexatilux (ranibizumab): CHMP positive opinion
Intas Third Party Sales 2005 S.L.; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Fovlussea Opinion · Accord Healthcare S.L.U.
- 🇪🇺 Lucentis Authorised · Novartis Europharm Limited
- 🇪🇺 Byooviz Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Epruvy (previously Ranibizumab Midas) Authorised · Midas Pharma GmbH
- 🇪🇺 Ximluci Authorised · STADA Arzneimittel AG
- 🇪🇺 Susvimo Authorised · Roche Registration GmbH
- 🇪🇺 Vislyfa Authorised · Lupin Europe GmbH
- 🇪🇺 Ranivisio Authorised · Midas Pharma GmbH
- 🇪🇺 Rimmyrah Authorised · Qilu Pharma Spain S.L.
- 🇺🇸 Nufymco Approved · Formycon Ag
- 🇺🇸 Ranluspec Approved · Lupin Limited
- 🇪🇺 Ranluspec Authorised · Lupin Europe GmbH
Follow Rexatilux
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.