Eptifibatide Accord
eptifibatide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Eptifibatide Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Eptifibatide Accord.
For practical information about using Eptifibatide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
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Eptifibatide Accord : EPAR - Summary for the public (PDF/101 KB)
First published: 18/01/2016
Last updated: 18/01/2016
EMA/20928/2016 -
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Eptifibatide Accord : EPAR - Risk-management-plan summary (PDF/43.09 KB)
First published: 18/01/2016
Last updated: 18/01/2016
EMA/20134/2016
Authorisation details
Product details | |
---|---|
Name |
Eptifibatide Accord
|
Agency product number |
EMEA/H/C/004104
|
Active substance |
eptifibatide
|
International non-proprietary name (INN) or common name |
eptifibatide
|
Therapeutic area (MeSH) |
Myocardial Infarction
|
Anatomical therapeutic chemical (ATC) code |
B01AC16
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
11/01/2016
|
Contact address |
Product information
30/09/2020 Eptifibatide Accord - EMEA/H/C/004104 - R/0010
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
Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.
Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.
Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).