Integrilin

RSS

eptifibatide

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 03/05/2017

Authorisation details

Product details
Name
Integrilin
Agency product number
EMEA/H/C/000230
Active substance
eptifibatide
International non-proprietary name (INN) or common name
eptifibatide
Therapeutic area (MeSH)
  • Angina, Unstable
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC16
Publication details
Marketing-authorisation holder
Glaxo Group Ltd
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
01/07/1999
Contact address
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

12/04/2017 Integrilin - EMEA/H/C/000230 - IB/0075

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

Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.

Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.

Patients most likely to benefit from Integrilin 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 percutaneous transluminal coronary angioplasty (PTCA).

Assessment history

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