Zontivity

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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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Zontivity has been withdrawn at the request of the marketing authorisation holder.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 monitoringAdditional 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

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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