Renagel (sevelamer)
- Region
- 🇪🇺 EU
- Active substance
- sevelamer
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Renal Dialysis; Hyperphosphatemia
- CHMP opinion
- Thu 23 Sep 1999
- EU approval
- Fri 28 Jan 2000
- Application
- EMEA/H/C/000254
- ATC
- V03AE02
- Official record
- www.ema.europa.eu
Indication
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 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
- 🇪🇺 Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Tasermity Lapsed · Genzyme Europe BV
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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.