Regulatory PathRegulatory requirements compared

Active substance

Sevelamer

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RENAGEL 800MG F.C.TABLET800 mgFilm-coated tablet · Oral use180 BottleSAR 980.40NCE · PrescriptionGENZYMEWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
RENAGEL400MG; 800MGtablet · oralGENZYMEPrescription12 Jul 2000
SEVELAMER HYDROCHLORIDE400MG; 800MGtablet · oralGLENMARK PHARMS LTDPrescription8 Feb 2019
SEVELAMER HYDROCHLORIDE400MG; 800MGtablet · oralLUPINPrescription16 Jun 2021
SEVELAMER HYDROCHLORIDE400MG; 800MGtablet · oralMACLEODS PHARMSPrescription26 May 2023
SEVELAMER HYDROCHLORIDE400MG; 800MGtablet · oralAUROBINDO PHARMA LTDPrescription11 Jul 2023
SEVELAMER HYDROCHLORIDE800MGtablet · oralNAVINTA LLCPrescription3 Feb 2025
RENAGEL403MGcapsule · oralGENZYMEDiscontinued30 Oct 1998
SEVELAMER HYDROCHLORIDE400MG; 800MGtablet · oralRISINGDiscontinued15 Dec 2020

EMA European Union — centrally authorised medicines

Renagel Sanofi Winthrop Industrie · Authorised · authorised 28 Jan 2000 · ATC V03AE02

Therapeutic indication (EMA)

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.

Tasermity Genzyme Europe BV · Lapsed · authorised 25 Feb 2015 · ATC V03AE02

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RENAGEL02244310800 MGTABLET · ORALSANOFI-AVENTIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSEVELAMER 0.8 GM POWDER PACKET$0.91959per EA23 Sep 2026
US NADACSEVELAMER 2.4 GM POWDER PACKET$1.00501per EA23 Sep 2026
US NADACSEVELAMER HCL 800 MG TABLET$0.69517per EA23 Sep 2026
NHS Drug TariffSevelamer 2.4g oral powder sachets sugar free£167.0460 sachet1 Oct 2026
NHS Drug TariffSevelamer 800mg oral powder sachets sugar free£83.5290 sachet1 Oct 2026
NHS Drug TariffSevelamer 800mg tablets£28.58180 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 30 Apr 2020 RENAGEL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sevelamer →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.