Trevaclyn

Withdrawn

This medicine's authorisation has been withdrawn

laropiprant / nicotinic acid

Overview

The marketing authorisation for Trevaclyn has been withdrawn at the request of the marketing-authorisation holder.

Trevaclyn : EPAR - Summary for the public

Product information

Trevaclyn : EPAR - Product Information

Latest procedure affecting product information: A20/0038

10/04/2013

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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).

Trevaclyn : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Trevaclyn
• 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

Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Trevaclyn 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).

Trevaclyn 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 Trevaclyn.

Authorisation details

• EMA product number:
  EMEA/H/C/000897
• Marketing authorisation holder:
  Merck Sharp Dohme Ltd

  Hertford Road; Hoddesdon; Hertfordshire; EN11 9BU; United Kingdom

• Marketing authorisation issued:
  03/07/2008
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

Trevaclyn : EPAR - Procedural steps taken and scientific information after authorisation

Trevaclyn : EPAR - Scientific Conclusion

Trevaclyn-H-C-897-A20-38 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/45910/2013

Initial marketing authorisation documents

Trevaclyn : EPAR - Public assessment report

CHMP summary of positive opinion for Trevaclyn

Reference Number: EMEA/CHMP/196882/2008