Zontivity
vorapaxar
Table of contents
Overview
The marketing authorisation for Zontivity has been withdrawn at the request of the marketing authorisation holder.
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List item
Zontivity : EPAR - Summary for the public (PDF/549.57 KB)
First published: 02/03/2015
Last updated: 20/09/2017
EMA/733103/2014 -
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List item
Zontivity : EPAR - Risk-management-plan summary (PDF/538.15 KB)
First published: 02/03/2015
Last updated: 20/09/2017
EMA/739006/2014
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.