Kengrexal

RSS

cangrelor

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

Overview

This is a summary of the European public assessment report (EPAR) for Kengrexal. 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 Kengrexal.

For practical information about using Kengrexal, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 26/04/2018

Authorisation details

Product details
Name
Kengrexal
Agency product number
EMEA/H/C/003773
Active substance
cangrelor
International non-proprietary name (INN) or common name
cangrelor
Therapeutic area (MeSH)
  • Acute Coronary Syndrome
  • Vascular Surgical Procedures
Anatomical therapeutic chemical (ATC) code
B01
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
23/03/2015
Contact address
Via Palermo 26/A
43122 Parma
Italy

Product information

12/04/2018 Kengrexal - EMEA/H/C/003773 - N/0013

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

Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.

Assessment history

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