Ranivisio (ranibizumab)
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Midas Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
- CHMP opinion
- Thu 23 Jun 2022
- EU approval
- Thu 25 Aug 2022
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005019
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Ranivisio 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
No milestones recorded in the last year.
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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.