Zontivity

RSS

vorapaxar

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zontivity has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 20/09/2017

Authorisation details

Product details
Name
Zontivity
Agency product number
EMEA/H/C/002814
Active substance
vorapaxar sulfate
International non-proprietary name (INN) or common name
vorapaxar
Therapeutic area (MeSH)
Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01
Additional monitoring

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

Publication details
Marketing-authorisation holder
Merck Sharp Dohme Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
19/01/2015
Contact address
Hertford Road
EN11 9BU Hoddesdon
United Kingdom

Product information

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

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.

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

How useful was this page?

Add your rating