Eptifibatide Accord

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eptifibatide

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

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.

This EPAR was last updated on 30/04/2019

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
GenericGeneric

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
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
11/01/2016
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

29/04/2019 Eptifibatide Accord - EMEA/H/C/004104 - N/0006

Contents

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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).

Assessment history

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