Epruvy (previously Ranibizumab Midas) (ranibizumab)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Midas Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Choroidal Neovascularization; Diabetes Complications
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Designations
- Biosimilar
- Application
- EMEA/H/C/006528
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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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.