Velphoro (sucroferric oxyhydroxide)
- Region
- 🇪🇺 EU
- Active substance
- sucroferric oxyhydroxide
- Company
- Vifor Fresenius Medical Care Renal Pharma France
- Status
- Authorised
- Therapeutic area
- Hyperphosphatemia; Renal Dialysis
- CHMP opinion
- Thu 26 Jun 2014
- EU approval
- Tue 26 Aug 2014
- Application
- EMEA/H/C/002705
- ATC
- V03AE05
- Official record
- www.ema.europa.eu
Indication
Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis. Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
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.