Efient
prasugrel
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Efient
|
Agency product number |
EMEA/H/C/000984
|
Active substance |
prasugrel
|
International non-proprietary name (INN) or common name |
prasugrel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B01AC22
|
Publication details | |
---|---|
Marketing-authorisation holder |
Daiichi Sankyo Europe GmbH
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
24/02/2009
|
Contact address |
Product information
22/10/2020 Efient - EMEA/H/C/000984 - IA/0032
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
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in 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).