Zontivity

vorapaxar

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The marketing authorisation for Zontivity has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Zontivity : EPAR - Summary for the public BG = bălgarski 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public ES = español 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public CS = čeština 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public DA = dansk 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public DE = Deutsch 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public ET = eesti keel 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public EL = elliniká 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public FR = français 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public IT = italiano 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public LV = latviešu valoda 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public LT = lietuvių kalba 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public HU = magyar 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public MT = Malti 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public NL = Nederlands 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public PL = polski 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public PT = português 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public RO = română 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public SK = slovenčina 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public SL = slovenščina 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public FI = suomi 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public SV = svenska 2015-03-02 2017-09-20
Zontivity : EPAR - Summary for the public HR = Hrvatski 2015-03-02 2017-09-20
Name Language First published Last updated
Zontivity : EPAR - Risk-management-plan summary (English only) 2015-03-02 2017-09-20

This EPAR was last updated on 20/09/2017 .

Authorisation details

Product details

Product details for Zontivity
NameZontivity
Agency product numberEMEA/H/C/002814
Active substance

vorapaxar sulfate

International non-proprietary name (INN) or common name

vorapaxar

Therapeutic area Myocardial Infarction
Anatomical therapeutic chemical (ATC) code B01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Zontivity
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/01/2015

Contact address:

Hertford Road 
EN11 9BU 
Hoddesdon 
United Kingdom

Product information

Product information

29/07/2016  Zontivity -EMEA/H/C/002814 -II/0005

Name Language First published Last updated
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - Product Information EN = English 2015-03-02 2017-09-20

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20
Zontivity : EPAR - All Authorised presentations EN = English 2015-03-02 2017-09-20

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zontivity : EPAR - Public assessment report EN = English 2015-03-02 2017-09-20
CHMP summary of positive opinion for Zontivity EN = English 2014-11-21 2017-09-20

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Zontivity