Regulatory PathRegulatory requirements compared

Active substance

Sevelamer carbonate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Celavas800 mgFilm-coated tablet · Oral use180 BottleSAR 452.95Generic · PrescriptionAlrai Pharmaceutical industry Co. (L.L.C)Valid
Lamsev 800800 mgFilm-coated tablet · Oral use180 BottleSAR 476.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
RENAPAT800 mgFilm-coated tablet · Oral use270 BottleSAR 475.55Generic · PrescriptionSUDAIR PHARMA COMPANYValid
RENOMER 800 MG FILM-COATED TABLET800 mgFilm-coated tablet · Oral use180 BottleSAR 529.75Generic · PrescriptionSPIMACO ADDWAEIHValid
RENVELA 2.4 g powder for oral suspension2.4 gPowder for oral suspension · Oral use60 SachetSAR 623.25NCE · PrescriptionGENZYMEValid
RENVELA 800 mg film-coated tablet800 mgFilm-coated tablet · Oral use180 Tablet ContainerSAR 623.25NCE · PrescriptionGENZYMEValid
Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDERS; HYPOPARATHYROIDISM; PEDIATRIC B-CELL LYMPHOMA

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralAUROBINDO PHARMAPrescription13 Jun 2017
SEVELAMER CARBONATE800MGtablet · oralAUROBINDO PHARMAPrescription17 Jul 2017
SEVELAMER CARBONATE800MGtablet · oralDR REDDYSPrescription29 Sep 2017
SEVELAMER CARBONATE800MGtablet · oralINVAGEN PHARMSPrescription26 Oct 2017
SEVELAMER CARBONATE800MGtablet · oralAMNEAL PHARMS COPrescription28 Nov 2017
SEVELAMER CARBONATE800MGtablet · oralQUAGENPrescription20 Mar 2018
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralDR REDDYSPrescription25 Oct 2018
SEVELAMER CARBONATE800MGtablet · oralRISINGPrescription29 Nov 2018
SEVELAMER CARBONATE800MGtablet · oralZYDUS PHARMSPrescription11 Aug 2020
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralIMPAXPrescription20 Nov 2020
SEVELAMER CARBONATE800MG/PACKETfor suspension · oralBIONPHARMAPrescription17 May 2021
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralCHARTWELL RXPrescription2 Mar 2023
SEVELAMER CARBONATE800MGtablet · oralMACLEODS PHARMSPrescription19 Apr 2023
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralSTRIDES PHARMA INTLPrescription8 Sep 2023
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralMACLEODS PHARMSPrescription25 Apr 2024
SEVELAMER CARBONATE800MGtablet · oralSTRIDES PHARMAPrescription9 May 2024
SEVELAMER CARBONATE800MGtablet · oralSHANDONG XINHUAPrescription24 Oct 2024
SEVELAMER CARBONATE800MGtablet · oralNAVINTA LLCPrescription27 Oct 2025
RENVELA800MGtablet · oralSANOFIDiscontinued19 Oct 2007
RENVELA800MG/PACKET; 2.4GM/PACKETfor suspension · oralGENZYMEDiscontinued12 Aug 2009
SEVELAMER CARBONATE800MGtablet · oralIMPAX LABS INCDiscontinued23 Oct 2017
SEVELAMER CARBONATE800MGtablet · oralEPIC PHARMA LLCDiscontinued9 Apr 2020
SEVELAMER CARBONATE800MGtablet · oralSTRIDES PHARMA INTLDiscontinued5 Aug 2020
SEVELAMER CARBONATE800MGtablet · oralCHARTWELL RXDiscontinued14 Jan 2021
SEVELAMER CARBONATE800MG/PACKET; 2.4GM/PACKETfor suspension · oralLUPINDiscontinued23 Dec 2021

3 more — full table

EMA European Union — centrally authorised medicines

Renvela Sanofi Winthrop Industrie · Authorised · authorised 9 Jun 2009 · ATC V03AE02

Therapeutic indication (EMA)

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.

Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) Sanofi Winthrop Industrie · Authorised · authorised 15 Jan 2015 · ATC V03AE02

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACCEL-SEVELAMER02461501800 MGTABLET · ORALACCEL PHARMA INC
RENVELA02354586800 MGTABLET · ORALSANOFI-AVENTIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRENVELA 800 MG TABLET$5.68515per EA22 Apr 2026
US NADACSEVELAMER CARBONATE 800 MG TAB$0.214per EA23 Sep 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 RENVELA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 30 Apr 2020 RENVELA — 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 carbonate →

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.