Overview

The marketing authorisation for Zontivity has been withdrawn at the request of the marketing authorisation holder.

Zontivity : EPAR - Summary for the public

Reference Number: EMA/733103/2014

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italiano (IT) (545.6 KB - PDF)

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latviešu valoda (LV) (614.26 KB - PDF)

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Suomi (FI) (545.31 KB - PDF)

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svenska (SV) (546.74 KB - PDF)

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Zontivity : EPAR - Risk-management-plan summary

Reference Number: EMA/739006/2014

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Product information

Zontivity : EPAR - Product Information

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čeština (CS) (1.65 MB - PDF)

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ελληνικά (EL) (1.99 MB - PDF)

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latviešu valoda (LV) (1.68 MB - PDF)

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slovenčina (SK) (1.6 MB - PDF)

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slovenščina (SL) (1.64 MB - PDF)

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Suomi (FI) (1.3 MB - PDF)

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svenska (SV) (1.15 MB - PDF)

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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)

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español (ES) (479.2 KB - PDF)

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čeština (CS) (495.84 KB - PDF)

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dansk (DA) (478.74 KB - PDF)

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Deutsch (DE) (476.03 KB - PDF)

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eesti keel (ET) (476.56 KB - PDF)

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ελληνικά (EL) (513.72 KB - PDF)

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français (FR) (479.35 KB - PDF)

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hrvatski (HR) (493.84 KB - PDF)

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íslenska (IS) (476.36 KB - PDF)

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italiano (IT) (475.94 KB - PDF)

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latviešu valoda (LV) (509.36 KB - PDF)

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lietuvių kalba (LT) (497.93 KB - PDF)

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magyar (HU) (495.04 KB - PDF)

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Malti (MT) (503.26 KB - PDF)

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Nederlands (NL) (477.88 KB - PDF)

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norsk (NO) (475.54 KB - PDF)

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polski (PL) (506.04 KB - PDF)

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português (PT) (478.9 KB - PDF)

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română (RO) (493.84 KB - PDF)

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slovenčina (SK) (497.53 KB - PDF)

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slovenščina (SL) (496.4 KB - PDF)

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Suomi (FI) (480.42 KB - PDF)

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svenska (SV) (476.2 KB - PDF)

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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
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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More information on Zontivity

Public statement on Zontivity: Cessation of validity of the marketing authorisation in the European Union

Reference Number: EMA/411700/2017

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