Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 14 November 2017

Indication(s)

- Sevelamer carbonate Zentiva 800 mg film-coated tablets

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

Sevelamer carbonate Zentiva 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 Zentiva 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.



- Sevelamer carbonate Zentiva 2.4 g powder for oral suspension

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

Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease patients not on dialysis with serum phosphorus > 1.78 mmol/L.

Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a Body Surface Area (BSA) of >0.75 m2) with chronic kidney disease.

Sevelamer carbonate Zentiva 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.

Full Prescribing information

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Category Value
Agency product number EMEA/H/C/003971
Orphan designation No
Date First Approved 15-01-2015
Type Medicinal product subject to medical prescription
Marketing authorisation holder Genzyme Europe BV