🇪🇺 Phosphate Binder Agents in European Union

EMA authorised Phosphate Binder Agents on 15 January 2015

Marketing authorisation

EMA — authorised 15 January 2015

  • Application: EMEA/H/C/003971
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
  • 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.
  • Status: approved

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Phosphate Binder Agents in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Phosphate Binder Agents approved in European Union?

Yes. EMA authorised it on 15 January 2015.

Who is the marketing authorisation holder for Phosphate Binder Agents in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.