US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Cholestagel CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 9 Mar 2004 · ATC C10AC04
Therapeutic indication (EMA)
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| APO-COLESEVELAM | 02494051 | 625 MG | TABLET · ORAL | APOTEX INC |
| JAMP COLESEVELAM | 02566869 | 625 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| LODALIS | 02373955 | 625 MG | TABLET · ORAL | BAUSCH HEALTH, CANADA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | COLESEVELAM 625 MG TABLET | $0.26171 | per EA | 23 Sep 2026 |
| US NADAC | COLESEVELAM HCL 3.75 G PACKET | $2.70422 | per EA | 23 Sep 2026 |
| US NADAC | WELCHOL 625 MG TABLET | $5.67166 | per EA | 1 Jul 2026 |
| NHS Drug Tariff | Colesevelam 625mg tablets | £115.32 | 180 tablet | 1 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.
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.