Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) (sevelamer carbonate)
- Region
- 🇪🇺 EU
- Active substance
- sevelamer carbonate
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Hyperphosphatemia; Renal Dialysis
- CHMP opinion
- Thu 20 Nov 2014
- EU approval
- Thu 15 Jan 2015
- Application
- EMEA/H/C/003971
- ATC
- V03AE02
- Official record
- www.ema.europa.eu
Indication
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L. Sevelamer carbonate Winthrop 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 to control the development of renal bone disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Renvela Authorised · Sanofi Winthrop Industrie
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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.