🇪🇺 Colesevelam hydrochloride film-coated tablets in European Union

EMA authorised Colesevelam hydrochloride film-coated tablets on 9 March 2004

Marketing authorisation

EMA — authorised 9 March 2004

  • Application: EMEA/H/C/000512
  • Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
  • Local brand name: Cholestagel
  • 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.
  • Status: approved

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Colesevelam hydrochloride film-coated tablets 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 Colesevelam hydrochloride film-coated tablets approved in European Union?

Yes. EMA authorised it on 9 March 2004.

Who is the marketing authorisation holder for Colesevelam hydrochloride film-coated tablets in European Union?

CHEPLAPHARM Arzneimittel GmbH holds the EU marketing authorisation.