Zontivity

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Withdrawn

This medicine's authorisation has been withdrawn

vorapaxar
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 23 June 2017 the European Commission withdrew the marketing authorisation for Zontivity (vorapaxar) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Zontivity was granted marketing authorisation in the EU on 19 January 2015 for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction. The approved indication was subsequently extended to include adult patients with symptomatic peripheral arterial disease. 

The European Public Assessment Report (EPAR) for Zontivity is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Zontivity : EPAR - Summary for the public

Reference Number: EMA/733103/2014

English (EN) (549.57 KB - PDF)

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български (BG) (633.29 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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español (ES) (547.87 KB - PDF)

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čeština (CS) (614.5 KB - PDF)

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dansk (DA) (545.41 KB - PDF)

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Deutsch (DE) (550.79 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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eesti keel (ET) (544.17 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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ελληνικά (EL) (636.04 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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français (FR) (549.89 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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hrvatski (HR) (573.91 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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italiano (IT) (545.6 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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latviešu valoda (LV) (614.26 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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lietuvių kalba (LT) (574.98 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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magyar (HU) (611.07 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Malti (MT) (617.97 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Nederlands (NL) (547.11 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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polski (PL) (612.51 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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português (PT) (548.44 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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română (RO) (575.49 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenčina (SK) (612.69 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenščina (SL) (607.05 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Suomi (FI) (545.31 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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svenska (SV) (546.74 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Zontivity : EPAR - Risk-management-plan summary

Reference Number: EMA/739006/2014

English (EN) (538.15 KB - PDF)

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Product information

Zontivity : EPAR - Product Information

English (EN) (1.22 MB - PDF)

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български (BG) (1.9 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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español (ES) (1.26 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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čeština (CS) (1.65 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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dansk (DA) (1.33 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Deutsch (DE) (1.34 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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eesti keel (ET) (1.15 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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ελληνικά (EL) (1.99 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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français (FR) (1.22 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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hrvatski (HR) (1.31 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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íslenska (IS) (1.27 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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italiano (IT) (1.32 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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latviešu valoda (LV) (1.68 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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lietuvių kalba (LT) (1.29 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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magyar (HU) (1.72 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Malti (MT) (1.81 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Nederlands (NL) (1.29 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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norsk (NO) (1.26 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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polski (PL) (1.8 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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português (PT) (1.18 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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română (RO) (1.33 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenčina (SK) (1.6 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenščina (SL) (1.64 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Suomi (FI) (1.3 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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svenska (SV) (1.15 MB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Latest procedure affecting product information: II/0005
29/07/2016
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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).

Zontivity : EPAR - All Authorised presentations

English (EN) (478.08 KB - PDF)

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български (BG) (517.85 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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español (ES) (479.2 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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čeština (CS) (495.84 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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dansk (DA) (478.74 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Deutsch (DE) (476.03 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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eesti keel (ET) (476.56 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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ελληνικά (EL) (513.72 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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français (FR) (479.35 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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hrvatski (HR) (493.84 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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íslenska (IS) (476.36 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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italiano (IT) (475.94 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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latviešu valoda (LV) (509.36 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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lietuvių kalba (LT) (497.93 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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magyar (HU) (495.04 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Malti (MT) (503.26 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Nederlands (NL) (477.88 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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norsk (NO) (475.54 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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polski (PL) (506.04 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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português (PT) (478.9 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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română (RO) (493.84 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenčina (SK) (497.53 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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slovenščina (SL) (496.4 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Suomi (FI) (480.42 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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svenska (SV) (476.2 KB - PDF)

First published: 02/03/2015Last updated: 20/09/2017
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Product details

Name of medicine
Zontivity
Active substance
vorapaxar sulfate
International non-proprietary name (INN) or common name
vorapaxar
Therapeutic area (MeSH)
Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Zontivityis indicated for the reduction of atherothrombotic events in adult patients with

  • a history of myocardial infarction (MI), ,co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or
  • symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel.

Authorisation details

EMA product number
EMEA/H/C/002814
Marketing authorisation holder
Merck Sharp Dohme Limited

Hertford Road
EN11 9BU Hoddesdon
United Kingdom

Marketing authorisation issued
19/01/2015
Withdrawal of marketing authorisation
23/06/2017
Revision
2

Assessment history

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

English (EN) (547.13 KB - PDF)

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Zontivity-H-C-2814-II-05: EPAR - EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/500315/2016

English (EN) (2.3 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Zontivity (II/0005)

AdoptedReference Number: EMA/CHMP/420912/2016

English (EN) (531.83 KB - PDF)

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Zontivity : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/85159/2015

English (EN) (4.69 MB - PDF)

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CHMP summary of positive opinion for Zontivity

AdoptedReference Number: EMA/CHMP/666694/2014

English (EN) (530.34 KB - PDF)

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