Pelzont

Withdrawn

This medicine's authorisation has been withdrawn

laropiprant / nicotinic acid

Overview

On the 3 July 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal products Pelzont (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 Pelzont was Merck Sharp & Dohme Ltd. 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 Pelzont. 

Pursuant to this decision the European Public Assessment Reports for Pelzont will be updated to reflect the fact that the marketing authorisations are no longer valid.

Pelzont : EPAR - Summary for the public

Product information

Pelzont : EPAR - Product Information

Pelzont : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pelzont
• 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

Pelzont 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).

Pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-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 Pelzont.

Authorisation details

• EMA product number:
  EMEA/H/C/000903
• Marketing authorisation holder:
  Merck Sharp Dohme Ltd

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

• Marketing authorisation issued:
  03/07/2008
• Withdrawal of marketing authorisation:
  10/04/2013
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

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

Pelzont : EPAR - Scientific Conclusion

Pelzont-H-C-903-A20-38 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/45910/2013

Initial marketing authorisation documents

Pelzont : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Pelzont

Reference Number: EMEA/CHMP/197000/2008