Vabysmo (faricimab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- faricimab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetes Complications
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Thu 15 Sep 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005642
- ATC
- S01L
- Official record
- www.ema.europa.eu
Indication
Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
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.