🇪🇺 sevelamer phosphate-binders in European Union

EMA authorised sevelamer phosphate-binders on 28 January 2000

Marketing authorisation

EMA — authorised 28 January 2000

  • Application: EMEA/H/C/000254
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Renagel
  • 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.
  • Status: approved

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sevelamer phosphate-binders 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 sevelamer phosphate-binders approved in European Union?

Yes. EMA authorised it on 28 January 2000.

Who is the marketing authorisation holder for sevelamer phosphate-binders in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.