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sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)

Phase 3
Sanofi (SNY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Drug Information

Target Indication

Chronic Kidney Disease

Clinical Trial

NCT00267514

Last updated: 12/12/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA1/15/2015

Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)

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.

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EMA6/9/2009

Renvela

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela 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. Renvela 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.

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EMA1/28/2000

Renagel

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.

View on EMA
Drug Science
Mechanism of action & safety profile
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