Vafseo (vadadustat)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- vadadustat
- Company
- Medice Arzneimittel Pütter GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Renal Insufficiency, Chronic; Anemia
- CHMP opinion
- Thu 23 Feb 2023
- EU approval
- Mon 24 Apr 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005131
- Official record
- www.ema.europa.eu
Indication
Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Regulatory milestones
No milestones recorded in the last year.
Follow Vafseo
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.