Brilique

ticagrelor

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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.

What is Brilique?

Brilique is a medicine that contains the active substance ticagrelor. It is available as round, yellow tablets (90 mg).

What is Brilique used for?

Brilique is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes. It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to the heart).

The medicine can only be obtained with a prescription.

How is Brilique used?

The starting dose of Brilique is two tablets taken at once, followed by a regular dose of one tablet taken twice a day. Patients should also be taking aspirin as directed by their doctor. The doctor may, for health reasons, tell them not to take aspirin. They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.

How does Brilique work?

The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.

How has Brilique been studied?

The effects of Brilique were first tested in experimental models before being studied in humans.

Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina. The patients also took aspirin and were treated for up to a year. The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.

What benefit has Brilique shown during the studies?

Brilique was shown to be beneficial to patients who have had a heart attack or unstable angina. In the main study, 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.

What is the risk associated with Brilique?

The most common side effects with Brilique (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured). For the full list of all side effects reported with Brilique, see the package leaflet.

Brilique should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients. It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain. It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4). These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).

Why has Brilique been approved?

The CHMP noted that the main study showed that, compared with clopidogrel, Brilique reduces the risk of heart attacks and cardiovascular deaths. However Brilique was not more effective than clopidogrel in reducing the risk of stroke.

The CHMP decided that Brilique’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Brilique

The European Commission granted a marketing authorisation valid throughout the European Union for Brilique to AstraZeneca on 3 December 2010. The marketing authorisation is valid for five years, after which it can be renewed. 

For more information about treatment with Brilique, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Brilique : EPAR - Summary for the public BG = bălgarski 07/01/2011  
Brilique : EPAR - Summary for the public ES = español 07/01/2011  
Brilique : EPAR - Summary for the public CS = čeština 07/01/2011  
Brilique : EPAR - Summary for the public DA = dansk 07/01/2011  
Brilique : EPAR - Summary for the public DE = Deutsch 07/01/2011  
Brilique : EPAR - Summary for the public ET = eesti keel 07/01/2011  
Brilique : EPAR - Summary for the public EL = elliniká 07/01/2011  
Brilique : EPAR - Summary for the public EN = English 07/01/2011  
Brilique : EPAR - Summary for the public FR = français 07/01/2011  
Brilique : EPAR - Summary for the public IT = italiano 07/01/2011  
Brilique : EPAR - Summary for the public LV = latviešu valoda 07/01/2011  
Brilique : EPAR - Summary for the public LT = lietuvių kalba 07/01/2011  
Brilique : EPAR - Summary for the public HU = magyar 07/01/2011  
Brilique : EPAR - Summary for the public MT = Malti 07/01/2011  
Brilique : EPAR - Summary for the public NL = Nederlands 07/01/2011  
Brilique : EPAR - Summary for the public PL = polski 07/01/2011  
Brilique : EPAR - Summary for the public PT = português 07/01/2011  
Brilique : EPAR - Summary for the public RO = română 07/01/2011  
Brilique : EPAR - Summary for the public SK = slovenčina 07/01/2011  
Brilique : EPAR - Summary for the public SL = slovenščina 07/01/2011  
Brilique : EPAR - Summary for the public FI = suomi 07/01/2011  
Brilique : EPAR - Summary for the public SV = svenska 07/01/2011  

This EPAR was last updated on 11/07/2014 .

Authorisation details

Product details

Product details for Brilique
NameBrilique
Agency product numberEMEA/H/C/001241
Active substance

ticagrelor

International non-proprietary name (INN) or common name

ticagrelor

Therapeutic area Peripheral Vascular DiseasesAcute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code B01AC24

Publication details

Publication details for Brilique
Marketing-authorisation holder

AstraZeneca AB

Revision5
Date of issue of marketing authorisation valid throughout the European Union03/12/2010

Contact address:

AstraZeneca AB
S-151 85 Södertälje
Sweden

Product information

Product information

27/02/2014  Brilique -EMEA/H/C/001241 -IG/0402

Name Language First published Last updated
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014
Brilique : EPAR - Product Information SV = svenska 07/01/2011 18/02/2014

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.


Name Language First published Last updated
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  
Brilique : EPAR - All Authorised presentations SV = svenska 07/01/2011  

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 (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]), including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Brilique : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 29/06/2012 11/07/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Brilique : EPAR - Public assessment report SV = svenska 07/01/2011  
CHMP summary of positive opinion for Brilique SV = svenska 24/09/2010  

Authorised

This medicine is approved for use in the European Union