This is a summary of the European public assessment report (EPAR) for Cholestagel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cholestagel.
Therapeutic Indication
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\).
Therapeutic Area (MeSH)
ATC Code
C10AC04
ATC Item
N/A
Pharmacotherapeutic Group
Lipid modifying agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| colesevelam (as hydrochloride) | N/A | colesevelam (as hydrochloride) |
EMA Name
Cholestagel
Medicine Name
Cholestagel
Aliases
N/ANo risk management plan link.
