Trevaclyn

RSS
Withdrawn

This medicine's authorisation has been withdrawn

laropiprant / nicotinic acid
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On the 3 July 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal products Trevaclyn (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 Trevaclyn 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 Trevaclyn. 

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European Public Assessment Reports for Trevaclyn is updated to reflect the fact that the marketing authorisations are no longer valid.

български (BG) (236.98 KB - PDF)

View

español (ES) (44.93 KB - PDF)

View

čeština (CS) (164.48 KB - PDF)

View

dansk (DA) (44.75 KB - PDF)

View

Deutsch (DE) (45.84 KB - PDF)

View

eesti keel (ET) (42.99 KB - PDF)

View

ελληνικά (EL) (170.72 KB - PDF)

View

français (FR) (45.45 KB - PDF)

View

italiano (IT) (44.93 KB - PDF)

View

latviešu valoda (LV) (165.1 KB - PDF)

View

lietuvių kalba (LT) (157.86 KB - PDF)

View

magyar (HU) (154.69 KB - PDF)

View

Malti (MT) (167.26 KB - PDF)

View

Nederlands (NL) (45.31 KB - PDF)

View

polski (PL) (171.6 KB - PDF)

View

português (PT) (45.36 KB - PDF)

View

română (RO) (153.16 KB - PDF)

View

slovenčina (SK) (159.24 KB - PDF)

View

slovenščina (SL) (151.27 KB - PDF)

View

Suomi (FI) (43.3 KB - PDF)

View

svenska (SV) (43.51 KB - PDF)

View

Product information

български (BG) (386.63 KB - PDF)

View

español (ES) (250.34 KB - PDF)

View

čeština (CS) (318.59 KB - PDF)

View

dansk (DA) (271.25 KB - PDF)

View

Deutsch (DE) (256.18 KB - PDF)

View

eesti keel (ET) (242.75 KB - PDF)

View

ελληνικά (EL) (436.1 KB - PDF)

View

français (FR) (292.06 KB - PDF)

View

íslenska (IS) (275.88 KB - PDF)

View

italiano (IT) (232.55 KB - PDF)

View

latviešu valoda (LV) (373.52 KB - PDF)

View

lietuvių kalba (LT) (314.12 KB - PDF)

View

magyar (HU) (306.42 KB - PDF)

View

Malti (MT) (322.27 KB - PDF)

View

Nederlands (NL) (243.81 KB - PDF)

View

norsk (NO) (232.28 KB - PDF)

View

polski (PL) (357.36 KB - PDF)

View

português (PT) (236.12 KB - PDF)

View

română (RO) (341.21 KB - PDF)

View

slovenčina (SK) (354.65 KB - PDF)

View

slovenščina (SL) (282.93 KB - PDF)

View

Suomi (FI) (253.44 KB - PDF)

View

svenska (SV) (246 KB - PDF)

View
Latest procedure affecting product information: A20/0038
10/04/2013
icon globe

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

български (BG) (126.28 KB - PDF)

View

español (ES) (34.63 KB - PDF)

View

čeština (CS) (122.38 KB - PDF)

View

dansk (DA) (35.36 KB - PDF)

View

Deutsch (DE) (30.87 KB - PDF)

View

eesti keel (ET) (27.98 KB - PDF)

View

ελληνικά (EL) (118.6 KB - PDF)

View

français (FR) (30.79 KB - PDF)

View

italiano (IT) (33.85 KB - PDF)

View

latviešu valoda (LV) (121.11 KB - PDF)

View

lietuvių kalba (LT) (122.68 KB - PDF)

View

magyar (HU) (122.65 KB - PDF)

View

Malti (MT) (119.84 KB - PDF)

View

Nederlands (NL) (34.11 KB - PDF)

View

polski (PL) (74.77 KB - PDF)

View

português (PT) (30.65 KB - PDF)

View

română (RO) (119.72 KB - PDF)

View

slovenčina (SK) (118.39 KB - PDF)

View

slovenščina (SL) (81.32 KB - PDF)

View

Suomi (FI) (34.27 KB - PDF)

View

svenska (SV) (34.61 KB - PDF)

View

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
Withdrawal of marketing authorisation
10/04/2013
Revision
11

Assessment history

български (BG) (683.63 KB - PDF)

View

español (ES) (570.47 KB - PDF)

View

čeština (CS) (631.16 KB - PDF)

View

dansk (DA) (526.48 KB - PDF)

View

Deutsch (DE) (530.84 KB - PDF)

View

eesti keel (ET) (527.29 KB - PDF)

View

ελληνικά (EL) (682.84 KB - PDF)

View

français (FR) (526.11 KB - PDF)

View

italiano (IT) (523.69 KB - PDF)

View

latviešu valoda (LV) (638.4 KB - PDF)

View

lietuvių kalba (LT) (567.28 KB - PDF)

View

magyar (HU) (619.56 KB - PDF)

View

Malti (MT) (638.74 KB - PDF)

View

Nederlands (NL) (524.86 KB - PDF)

View

polski (PL) (633.08 KB - PDF)

View

português (PT) (526.29 KB - PDF)

View

română (RO) (563 KB - PDF)

View

slovenčina (SK) (626.93 KB - PDF)

View

slovenščina (SL) (625.17 KB - PDF)

View

Suomi (FI) (524.96 KB - PDF)

View

svenska (SV) (526.11 KB - PDF)

View

This page was last updated on

Share this page