Efient

RSS

prasugrel

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

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).

This EPAR was last updated on 04/12/2018

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)
  • Acute Coronary Syndrome
  • Angina, Unstable
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC22
Publication details
Marketing-authorisation holder
Daiichi Sankyo Europe GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
24/02/2009
Contact address
Zielstattstrasse 48
81379 Munich
Germany

Product information

22/11/2018 Efient - EMEA/H/C/000984 - PSUSA/00002499/201802

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).

Assessment history

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