Zontivity

Withdrawn

This medicine's authorisation has been withdrawn

vorapaxar

Overview

On 23 June 2017 the European Commission withdrew the marketing authorisation for Zontivity (vorapaxar) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Zontivity was granted marketing authorisation in the EU on 19 January 2015 for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction. The approved indication was subsequently extended to include adult patients with symptomatic peripheral arterial disease. 

The European Public Assessment Report (EPAR) for Zontivity is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Zontivity : EPAR - Summary for the public

Reference Number: EMA/733103/2014

Zontivity : EPAR - Risk-management-plan summary

Reference Number: EMA/739006/2014

Product information

Zontivity : EPAR - Product Information

Zontivity : EPAR - All Authorised presentations

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
• Withdrawal of marketing authorisation:
  23/06/2017
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Zontivity : EPAR - Procedural steps taken and scientific information after authorisation

Zontivity-H-C-2814-II-05: EPAR - EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/500315/2016

CHMP post-authorisation summary of positive opinion for Zontivity (II/0005)

Adopted Reference Number: EMA/CHMP/420912/2016

Initial marketing authorisation documents

Zontivity : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/85159/2015

CHMP summary of positive opinion for Zontivity

Adopted Reference Number: EMA/CHMP/666694/2014