Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Brilique   
Auth. number : EU/1/10/655
Active substance : ticagrelor
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding Heparin
Chemical substance: B01AC24 - Ticagrelor
(See WHO ATC Index)
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).
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje, Sverige
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/12/2010 Centralised - Authorisation EMEA/H/C/1241 (2010)8908 of 03/12/2010
26/10/2011 Centralised - Variation EMEA/H/C/1241/IB/1
Updated with Decision(2012)3294 of 14/05/2012
16/05/2012 Centralised - Variation (2012)3294 of 14/05/2012
26/10/2012 Centralised - Variation EMEA/H/C/1241/WS/292 (2012)7650 of 24/10/2012
25/07/2013 Centralised - Variation EMEA/H/C/1241/II/17
Updated with Decision(2014)4369 of 23/06/2014
21/11/2013 Centralised - Variation EMEA/H/C/1241/II/22
Updated with Decision(2014)4369 of 23/06/2014
25/06/2014 Centralised - Yearly update (2014)4369 of 23/06/2014
24/07/2014 Centralised - Variation EMEA/H/C/1241/II/21
Updated with Decision(2015)5143 of 17/07/2015
24/07/2014 Centralised - Variation EMEA/H/C/1241/II/22
Updated with Decision(2015)5143 of 17/07/2015
21/07/2015 Centralised - Renewal EMEA/H/C/1241/R/27 (2015)5143 of 17/07/2015