Pelzont

RSS
Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Pelzont has been withdrawn at the request of the marketing-authorisation holder.

Pelzont : EPAR - Summary for the public

English (EN) (486.41 KB - PDF)

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български (BG) (1.26 MB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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español (ES) (966.42 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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čeština (CS) (1.14 MB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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dansk (DA) (965.43 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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Deutsch (DE) (967.65 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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eesti keel (ET) (499.16 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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ελληνικά (EL) (1.2 MB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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français (FR) (504.69 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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italiano (IT) (503.68 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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latviešu valoda (LV) (653.16 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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lietuvių kalba (LT) (616.31 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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magyar (HU) (651.35 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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Malti (MT) (665.65 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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Nederlands (NL) (504.09 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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polski (PL) (670.16 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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português (PT) (504.36 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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română (RO) (614.33 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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slovenčina (SK) (641.72 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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slovenščina (SL) (646.47 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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Suomi (FI) (499.68 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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svenska (SV) (500.16 KB - PDF)

First published: 10/07/2008Last updated: 10/07/2008
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Product information

Pelzont : EPAR - Product Information

English (EN) (1.51 MB - PDF)

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български (BG) (3.1 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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español (ES) (1.5 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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čeština (CS) (2.54 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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dansk (DA) (1.52 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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Deutsch (DE) (1.55 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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eesti keel (ET) (890.76 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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ελληνικά (EL) (3.2 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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français (FR) (868.49 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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íslenska (IS) (916.69 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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italiano (IT) (911.64 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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latviešu valoda (LV) (1.49 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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lietuvių kalba (LT) (1010.11 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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magyar (HU) (1.47 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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Malti (MT) (1.48 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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Nederlands (NL) (891.94 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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norsk (NO) (868.12 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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polski (PL) (1.57 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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português (PT) (903.46 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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română (RO) (1.03 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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slovenčina (SK) (1.46 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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slovenščina (SL) (1.43 MB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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Suomi (FI) (910.64 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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svenska (SV) (939.4 KB - PDF)

First published: 14/09/2009Last updated: 04/06/2012
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Latest procedure affecting product information: A20/0038
10/04/2013
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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).

Pelzont : EPAR - All Authorised presentations

English (EN) (471.11 KB - PDF)

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български (BG) (1.1 MB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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español (ES) (949.74 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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čeština (CS) (1.04 MB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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dansk (DA) (951 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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Deutsch (DE) (941.41 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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eesti keel (ET) (487.69 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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ελληνικά (EL) (1.04 MB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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français (FR) (487 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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italiano (IT) (492.21 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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latviešu valoda (LV) (592.77 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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lietuvių kalba (LT) (580.96 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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magyar (HU) (592.73 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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Malti (MT) (590.82 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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Nederlands (NL) (494.12 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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polski (PL) (546 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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português (PT) (487.25 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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română (RO) (577.66 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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slovenčina (SK) (587.81 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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slovenščina (SL) (551.03 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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Suomi (FI) (490.95 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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svenska (SV) (493.32 KB - PDF)

First published: 26/01/2009Last updated: 26/01/2009
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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
Revision
11

Assessment history

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

English (EN) (641.49 KB - PDF)

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Pelzont : EPAR - Scientific Conclusion

English (EN) (486.38 KB - PDF)

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български (BG) (684.89 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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español (ES) (1.02 MB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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čeština (CS) (632.39 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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dansk (DA) (527.75 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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Deutsch (DE) (532.05 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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eesti keel (ET) (528.54 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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ελληνικά (EL) (684.1 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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français (FR) (527.41 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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italiano (IT) (524.9 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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latviešu valoda (LV) (639.62 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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lietuvių kalba (LT) (568.54 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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magyar (HU) (620.82 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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Malti (MT) (639.97 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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Nederlands (NL) (526.11 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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polski (PL) (634.37 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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português (PT) (527.51 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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română (RO) (564.26 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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slovenčina (SK) (628.1 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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slovenščina (SL) (626.37 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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Suomi (FI) (526.22 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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svenska (SV) (527.37 KB - PDF)

First published: 22/03/2013Last updated: 22/03/2013
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Pelzont-H-C-903-A20-38 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/45910/2013

English (EN) (711.2 KB - PDF)

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Pelzont : EPAR - Public assessment report

English (EN) (1.23 MB - PDF)

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

Reference Number: EMEA/CHMP/197000/2008

English (EN) (33.72 KB - PDF)

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More information on Pelzont

Public statement on Pelzont: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/285239/2013

English (EN) (71.75 KB - PDF)

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