Brilique

RSS

ticagrelor

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Brilique. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Brilique.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Brilique
Agency product number
EMEA/H/C/001241
Active substance
ticagrelor
International non-proprietary name (INN) or common name
ticagrelor
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
B01AC24
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
03/12/2010
Contact address
151 85 Södertälje
Sweden

Product information

18/05/2017 Brilique - EMEA/H/C/001241 - IA/0036/G

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

Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with

  • acute coronary syndromes (ACS) or
  • a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event

Brilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.

Assessment history

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