Angiox

bivalirudin

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Angiox. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Angiox.

What is Angiox?

Angiox is a medicine that contains the active substance bivalirudin. It is available as a powder that is made up into a solution for injection or infusion (drip) into a vein.

What is Angiox used for?

Angiox is used to prevent blood clots in adults who are undergoing percutaneous coronary intervention (PCI), a non-surgical procedure used to unblock the heart’s blood vessels. This includes patients who are having myocardial infarction (a heart attack) with ‘ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG).

Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are waiting for further treatment such as PCI, a heart bypass or using other medicines.

Angiox is used together with aspirin and clopidogrel (other medicines that help to prevent blood clots).

The medicine can only be obtained with a prescription.

How is Angiox used?

Angiox should be given by a doctor who has experience in the emergency care of patients with heart problems or in carrying out procedures on the heart.

The dose of Angiox and the duration of treatment depend on why it is being used. The first dose is given by injection into a vein, which must be followed immediately by an infusion for at least the duration of the procedure. In patients being treated for angina or myocardial infarction without ST segment elevation, the duration of the infusion depends on how the patient is going to be treated. The rate of the infusion needs to be reduced in patients with moderate kidney problems who are undergoing PCI.

For more information, see the summary of product characteristics (also part of the EPAR).

How does Angiox work?

Blood clotting can be a problem when blood clots develop inside blood vessels and restrict the blood flow to major organs such as the heart and the brain. Angiox is an anticoagulant, which means that it prevents the blood from clotting. The active substance in Angiox, bivalirudin, is a synthetic substance originally derived from hirudin, the anticoagulant substance produced by leeches. It specifically blocks one of the substances involved in the clotting process called thrombin. Thrombin is central to the processes involved in blood clotting. Using Angiox greatly reduces the risk of a blood clot forming. This can improve the effectiveness of PCI and help to maintain the flow of blood to the heart in patients with angina or myocardial infarction.

How has Angiox been studied?

In PCI, Angiox has been compared withanother type of anticoagulant, a heparin, in two studies involving a total of almost 10,000 adults. Heparin was given in combination with a glycoprotein IIb/IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots) and some patients receiving Angiox were also given a GPI where appropriate. Almost 4,000 of the patients were having PCI to treat myocardial infarction with ST segment elevation.

In patients with unstable angina or myocardial infarction without ST segment elevation waiting for further treatment, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.

In all three studies, the patients also received other medicines to prevent blood clots, such as aspirin and clopidogrel. The main measure of effectiveness was the reduction in the number of patients who had an ‘ischaemic event’ (a problem caused by reduced blood flow) including death, a heart attack, urgent revascularisation (restoration of blood flow to the heart) or stroke after 30 days. The studies also looked at the number of patients who had major bleeding.

What benefit has Angiox shown during the studies?

In both studies of patients undergoing PCI, Angiox (alone or with a GPI where appropriate) was as effective as heparin in combination with a GPI at preventing new ischaemic events. When used to treat unstable angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations. It was most effective in patients who also took aspirin and clopidogrel. Major bleeding was less common with Angiox alone than with heparin plus GPI.

What is the risk associated with Angiox?

The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding. For the full list of all side effects reported with Angiox, see the package leaflet.

Angiox must not be used in people whoare hypersensitive (allergic) to bivalirudin, other hirudins, or any of the other ingredients. It must also not be used in patients who have recently been bleeding, or who have severe high blood pressure, severe kidney problems or a heart infection. For the full list of restrictions, see the package leaflet.

Why has Angiox been approved?

The CHMP concluded that Angiox is an acceptable substitute for heparin during PCI and in the treatment of unstable angina and myocardial infarction. It decided that Angiox’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Angiox?

The company that makes Angiox will provide all doctors who are expected to prescribe the medicine with training and educational materials on how to use it correctly, including dosing instructions.

Other information about Angiox

The European Commission granted a marketing authorisation valid throughout the European Union for Angiox on 20 September 2004.

For more information about treatment with Angiox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Angiox : EPAR - Summary for the public BG = bălgarski 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public ES = español 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public CS = čeština 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public DA = dansk 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public DE = Deutsch 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public ET = eesti keel 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public EL = elliniká 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public EN = English 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public FR = français 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public IT = italiano 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public LV = latviešu valoda 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public LT = lietuvių kalba 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public HU = magyar 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public MT = Malti 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public NL = Nederlands 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public PL = polski 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public PT = português 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public RO = română 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public SK = slovenčina 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public SL = slovenščina 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public FI = suomi 02/09/2009 24/07/2013
Angiox : EPAR - Summary for the public SV = svenska 02/09/2009 24/07/2013

This EPAR was last updated on 11/07/2014 .

Authorisation details

Product details

Product details for Angiox
NameAngiox
Agency product numberEMEA/H/C/000562
Active substance

bivalirudin

International non-proprietary name (INN) or common name

bivalirudin

Therapeutic area Angioplasty, Transluminal, Percutaneous CoronaryAcute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code B01AE06

Publication details

Publication details for Angiox
Marketing-authorisation holder

The Medicines Company UK Ltd

Revision17
Date of issue of marketing authorisation valid throughout the European Union20/09/2004

Contact address:

The Medicines Company UK Ltd
115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom

Product information

Product information

23/06/2014  Angiox -EMEA/H/C/000562 -R/0052

Name Language First published Last updated
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014
Angiox : EPAR - Product Information SV = svenska 02/09/2009 11/07/2014

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.


Name Language First published Last updated
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011
Angiox : EPAR - All Authorised presentations SV = svenska 07/12/2005 08/07/2011

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Angiox : EPAR - Procedural steps taken before authorisation SV = svenska 07/12/2005  
Angiox : EPAR - Scientific Discussion SV = svenska 07/12/2005