Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Efient   
Auth. number : EU/1/08/503
INN : prasugrel
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: B01AC22 - Prasugrel
(See WHO ATC Index)
Indication: Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland

  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
27/02/2009 Centralised - Authorisation EMEA/H/C/984 (2009)1395 of 25/02/2009
27/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/984 (2009)1396 of 25/02/2009
18/05/2009 Centralised - Variation EMEA/H/C/984/IA/1
Updated with Decision(2009)10396 of 14/12/2009
25/06/2009 Centralised - Variation EMEA/H/C/984/N/2
Updated with Decision(2009)10396 of 14/12/2009
22/09/2009 Centralised - Variation EMEA/H/C/984/IA/4
Updated with Decision(2009)10396 of 14/12/2009
23/09/2009 Centralised - Variation EMEA/H/C/984/IA/3
Updated with Decision(2009)10396 of 14/12/2009
17/11/2009 Centralised - Variation EMEA/H/C/984/N/5
Updated with Decision(2009)10396 of 14/12/2009
16/12/2009 Centralised - Variation (2009)10396 of 14/12/2009
18/04/2011 Centralised - Variation EMEA/H/C/984/IA/7/G
28/04/2011 Centralised - Variation EMEA/H/C/984/II/6 (2011)2950 of 20/04/2011
26/10/2011 Centralised - Variation EMEA/H/C/984/II/8 (2011)7800 of 24/10/2011
28/09/2012 Centralised - Variation EMEA/H/C/984/N/9
Updated with Decision(2013)8074 of 13/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/984/II/12
Updated with Decision(2013)8074 of 13/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/984/II/11
Updated with Decision(2013)8074 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/984/R/13 (2013)8074 of 13/11/2013
23/12/2013 Centralised - Variation EMEA/H/C/984/II/14 (2013)9754 of 18/12/2013