<p>On the 3 July 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal products Tredaptive (nicotinic acid/laropiprant), which had been approved for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDLcholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and nonfamilial). The marketing authorisation holder (MAH) responsible for Tredaptive was Merck Sharp & Dohme Ltd.</p><p>The European Commission was notified by a letter dated 20 March 2013 of the MAH’s decision to voluntarily withdraw the marketing authorisations. This followed the CHMP’ recommendation to suspend the marketing authorisations of these products on 17 January 2013. None of the products are currently marketed in any EU country. On 10 April 2013 the European Commission issued a decision to withdraw the marketing authorisations for Tredaptive. </p><p>Pursuant to this decision the European Public Assessment Reports for Tredaptive is updated to reflect the fact that the marketing authorisations are no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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).</p> <p>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.</p></div>
Therapeutic Area (MeSH)
ATC Code
C10AD52
ATC Item
N/A
Pharmacotherapeutic Group
Lipid modifying agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| laropiprant | N/A | laropiprant |
| nicotinic acid | N/A | nicotinic acid |
EMA Name
Tredaptive
Medicine Name
Tredaptive
Aliases
N/ANo risk management plan link.
