Tredaptive

RSS

laropiprant / nicotinic acid

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Tredaptive has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 16/05/2013

Authorisation details

Product details
Name
Tredaptive
Agency product number
EMEA/H/C/000889
Active substance
laropiprant / nicotinic acid
International non-proprietary name (INN) or common name
laropiprant / nicotinic acid
Therapeutic area (MeSH)
Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10AD52
Publication details
Marketing-authorisation holder
Merck Sharp Dohme Ltd.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
03/07/2008
Contact address
Merck Sharp Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

10/04/2013 Tredaptive - EMEA/H/C/000889 - A20/0038

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

LIPID MODIFYING AGENTS

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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