Angiox

Withdrawn

This medicine's authorisation has been withdrawn

bivalirudin

MedicineHumanWithdrawn

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Application under evaluation
CHMP opinion
European Commission decision

Overview

On 21 June 2018, the European Commission withdrew the marketing authorisation for Angiox (bivalirudin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, The Medicines Company UK Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Angiox was granted marketing authorisation in the EU on 20 September 2004 and was 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 was 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 was to be administered with acetylsalicylic acid and clopidogrel. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2009. It was then granted unlimited validity in 2014.

The European Public Assessment Report (EPAR) for Angiox is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Angiox : EPAR - Summary for the public

English (EN) (544.74 KB - PDF)

Első közzététel: 02/09/2009 Legutóbb frissítve: 14/09/2018

Egyéb nyelvek (21)

Product information

Angiox : EPAR - Product Information

English (EN) (1.09 MB - PDF)

Első közzététel: 02/09/2009 Legutóbb frissítve: 14/09/2018

Egyéb nyelvek (24)

Angiox : EPAR - Product Information

English (EN) (1.09 MB - PDF)

Első közzététel: 02/09/2009 Legutóbb frissítve: 14/09/2018

Egyéb nyelvek (24)

Latest procedure affecting product information:EMEA/H/C/000562/IB/0070

25/10/2016

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).

Angiox : EPAR - All Authorised presentations

English (EN) (465.02 KB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

Egyéb nyelvek (23)

Angiox : EPAR - All Authorised presentations

English (EN) (465.02 KB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

Egyéb nyelvek (23)

Product details

Name of medicine: Angiox
Active substance: Bivalirudin
International non-proprietary name (INN) or common name: bivalirudin
Therapeutic area (MeSH): Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code: B01AE06

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.

Authorisation details

EMA product number: EMEA/H/C/000562
Marketing authorisation holder: The Medicines Company UK Ltd
115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom
Marketing authorisation issued: 20/09/2004
Withdrawal of marketing authorisation: 21/06/2018
Revision: 22

Assessment history

Angiox : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (973.62 KB - PDF)

Első közzététel: 02/09/2009 Legutóbb frissítve: 14/09/2018

Angiox : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (973.62 KB - PDF)

Első közzététel: 02/09/2009 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-P46-0025 : EPAR - Assessment Report

Adopted Reference Number: EMA/588962/2014

English (EN) (1.06 MB - PDF)

Első közzététel: 29/09/2014 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-P46-0025 : EPAR - Assessment Report

Adopted Reference Number: EMA/588962/2014

English (EN) (1.06 MB - PDF)

Első közzététel: 29/09/2014 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-A20-0042: EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/302474/2012

English (EN) (566.62 KB - PDF)

Első közzététel: 29/06/2012 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-A20-0042: EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/302474/2012

English (EN) (566.62 KB - PDF)

Első közzététel: 29/06/2012 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-II-0024 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/724835/2009

English (EN) (925.33 KB - PDF)

Első közzététel: 12/02/2010 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-II-0024 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/724835/2009

English (EN) (925.33 KB - PDF)

Első közzététel: 12/02/2010 Legutóbb frissítve: 14/09/2018

CHMP post-authorisation summary of positive opinion for Angiox 22 October 2009

Adopted Reference Number: EMEA/CHMP/671740/2009

English (EN) (487.08 KB - PDF)

Első közzététel: 22/10/2009 Legutóbb frissítve: 14/09/2018

CHMP post-authorisation summary of positive opinion for Angiox 22 October 2009

Adopted Reference Number: EMEA/CHMP/671740/2009

English (EN) (487.08 KB - PDF)

Első közzététel: 22/10/2009 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-II-08 : EPAR - Scientific Discussion - Variation

Adopted

English (EN) (831.05 KB - PDF)

Első közzététel: 23/01/2008 Legutóbb frissítve: 14/09/2018

Angiox-H-C-562-II-08 : EPAR - Scientific Discussion - Variation

Adopted

English (EN) (831.05 KB - PDF)

Első közzététel: 23/01/2008 Legutóbb frissítve: 14/09/2018

Angiox : EPAR - Scientific Discussion

English (EN) (1.03 MB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

Angiox : EPAR - Procedural steps taken before authorisation

English (EN) (541.99 KB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

Angiox : EPAR - Scientific Discussion

English (EN) (1.03 MB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

Angiox : EPAR - Procedural steps taken before authorisation

English (EN) (541.99 KB - PDF)

Első közzététel: 07/12/2005 Legutóbb frissítve: 14/09/2018

News on Angiox

This page was last updated on 14/09/2018