Angiox

bivalirudin

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.

List item

Angiox : EPAR - Summary for the public (PDF/544.74 KB)

First published: 02/09/2009
Last updated: 14/09/2018
- Bulgarian
  (PDF/632.54 KB)
- Czech
  (PDF/614.27 KB)
- Danish
  (PDF/545.82 KB)
- Dutch
  (PDF/548.82 KB)
- Estonian
  (PDF/545.75 KB)
- Finnish
  (PDF/545.4 KB)
- French
  (PDF/548.45 KB)
- German
  (PDF/548.07 KB)
- Greek
  (PDF/640.86 KB)
- Hungarian
  (PDF/609.65 KB)
- Italian
  (PDF/546.6 KB)
- Latvian
  (PDF/611.58 KB)
- Lithuanian
  (PDF/576.17 KB)
- Maltese
  (PDF/616.57 KB)
- Polish
  (PDF/611.2 KB)
- Portuguese
  (PDF/547.32 KB)
- Romanian
  (PDF/573.59 KB)
- Slovak
  (PDF/614.2 KB)
- Slovenian
  (PDF/603.81 KB)
- Spanish
  (PDF/547.09 KB)
- Swedish
  (PDF/546.46 KB)

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	20/09/2004
Contact address	115 L Milton Park Abingdon Oxfordshire OX14 4SA United Kingdom

Product information

25/10/2016 Angiox - EMEA/H/C/000562 - EMEA/H/C/000562/IB/0070

List item

Angiox : EPAR - Product Information (PDF/1.09 MB)

First published: 02/09/2009
Last updated: 14/09/2018
- Bulgarian
  (PDF/2.07 MB)
- Croatian
  (PDF/1.18 MB)
- Czech
  (PDF/1.72 MB)
- Danish
  (PDF/1.09 MB)
- Dutch
  (PDF/1.2 MB)
- Estonian
  (PDF/1.06 MB)
- Finnish
  (PDF/1.14 MB)
- French
  (PDF/1.2 MB)
- German
  (PDF/1.16 MB)
- Greek
  (PDF/2.07 MB)
- Hungarian
  (PDF/1.7 MB)
- Icelandic
  (PDF/1.11 MB)
- Italian
  (PDF/1.25 MB)
- Latvian
  (PDF/1.74 MB)
- Lithuanian
  (PDF/1.24 MB)
- Maltese
  (PDF/1.73 MB)
- Norwegian
  (PDF/1.08 MB)
- Polish
  (PDF/1.75 MB)
- Portuguese
  (PDF/1.08 MB)
- Romanian
  (PDF/1.25 MB)
- Slovak
  (PDF/1.73 MB)
- Slovenian
  (PDF/1.67 MB)
- Spanish
  (PDF/1.09 MB)
- Swedish
  (PDF/1.09 MB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Angiox : EPAR - All Authorised presentations (PDF/465.02 KB)

First published: 07/12/2005
Last updated: 14/09/2018
- Bulgarian
  (PDF/554.21 KB)
- Czech
  (PDF/514.49 KB)
- Danish
  (PDF/461.68 KB)
- Dutch
  (PDF/461.6 KB)
- Estonian
  (PDF/461.5 KB)
- Finnish
  (PDF/461.65 KB)
- French
  (PDF/461.79 KB)
- German
  (PDF/461.83 KB)
- Greek
  (PDF/519.73 KB)
- Hungarian
  (PDF/474.27 KB)
- Icelandic
  (PDF/482.08 KB)
- Italian
  (PDF/461.47 KB)
- Latvian
  (PDF/518.88 KB)
- Lithuanian
  (PDF/501.71 KB)
- Maltese
  (PDF/563.32 KB)
- Norwegian
  (PDF/481.92 KB)
- Polish
  (PDF/519.73 KB)
- Portuguese
  (PDF/461.48 KB)
- Romanian
  (PDF/546.18 KB)
- Slovak
  (PDF/514.24 KB)
- Slovenian
  (PDF/490.49 KB)
- Spanish
  (PDF/461.5 KB)
- Swedish
  (PDF/461.91 KB)

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

Table of contents

Overview

Angiox : EPAR - Summary for the public (PDF/544.74 KB)

Authorisation details

Product information

Angiox : EPAR - Product Information (PDF/1.09 MB)

Angiox : EPAR - All Authorised presentations (PDF/465.02 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Angiox : EPAR - Procedural steps taken and scientific information after authorisation (PDF/973.62 KB)

Angiox-H-C-562-P46-0025 : EPAR - Assessment Report (PDF/1.06 MB)

Angiox-H-C-562-A20-0042: EPAR - Assessment Report - Article 20 (PDF/566.62 KB)

Angiox-H-C-562-II-0024 : EPAR - Assessment Report - Variation (PDF/925.33 KB)

CHMP post-authorisation summary of positive opinion for Angiox 22 October 2009 (PDF/487.08 KB)

Angiox-H-C-562-II-08 : EPAR - Scientific Discussion - Variation (PDF/831.05 KB)

Initial marketing-authorisation documents

Angiox : EPAR - Scientific Discussion (PDF/1.03 MB)

Angiox : EPAR - Procedural steps taken before authorisation (PDF/541.99 KB)

News

More information on Angiox

Public statement on Angiox: Withdrawal of the marketing authorisation in the European Union (PDF/59.72 KB)

Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories (PDF/188.14 KB)

Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories (PDF/71.91 KB)

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