laropiprant / nicotinic acid
The marketing authorisation for Tredaptive has been withdrawn at the request of the marketing-authorisation holder.
Tredaptive : EPAR - Summary for the public (PDF/484.95 KB)
First published: 11/07/2008
Last updated: 11/07/2008
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp Dohme Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
Merck Sharp Dohme Ltd
10/04/2013 Tredaptive - EMEA/H/C/000889 - A20/0038
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Lipid modifying agents
Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 201318/01/2013