Angiox

RSS

bivalirudin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/09/2018

Authorisation details

Product details
Name
Angiox
Agency product number
EMEA/H/C/000562
Active substance
Bivalirudin
International non-proprietary name (INN) or common name
bivalirudin
Therapeutic area (MeSH)
Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
B01AE06
Publication details
Marketing-authorisation holder
The Medicines Company UK Ltd
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
19/09/2004
Contact address
115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom

Product information

24/10/2016 Angiox - EMEA/H/C/000562 - EMEA/H/C/000562/IB/0070

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

Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.

Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.

Angiox should be administered with aspirin and clopidogrel.

Assessment history

How useful was this page?

Add your rating