Angiox
Withdrawn
This medicine's authorisation has been withdrawn
bivalirudin
MedicineHumanWithdrawn
- 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Assessment Report (EPAR) for Angiox is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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)
First published: Last updated:
български (BG) (632.54 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
español (ES) (547.09 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
čeština (CS) (614.27 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
dansk (DA) (545.82 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Deutsch (DE) (548.07 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
eesti keel (ET) (545.75 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
ελληνικά (EL) (640.86 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
français (FR) (548.45 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
italiano (IT) (546.6 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
latviešu valoda (LV) (611.58 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
lietuvių kalba (LT) (576.17 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
magyar (HU) (609.65 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Malti (MT) (616.57 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Nederlands (NL) (548.82 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
polski (PL) (611.2 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
português (PT) (547.32 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
română (RO) (573.59 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenčina (SK) (614.2 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenščina (SL) (603.81 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Suomi (FI) (545.4 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
svenska (SV) (546.46 KB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Product information
Angiox : EPAR - Product Information
English (EN) (1.09 MB - PDF)
First published: Last updated:
български (BG) (2.07 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
español (ES) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
čeština (CS) (1.72 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
dansk (DA) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Deutsch (DE) (1.16 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
eesti keel (ET) (1.06 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
ελληνικά (EL) (2.07 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
français (FR) (1.2 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
hrvatski (HR) (1.18 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
íslenska (IS) (1.11 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
italiano (IT) (1.25 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
latviešu valoda (LV) (1.74 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
lietuvių kalba (LT) (1.24 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
magyar (HU) (1.7 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Malti (MT) (1.73 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Nederlands (NL) (1.2 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
norsk (NO) (1.08 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
polski (PL) (1.75 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
português (PT) (1.08 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
română (RO) (1.25 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenčina (SK) (1.73 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenščina (SL) (1.67 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Suomi (FI) (1.14 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
svenska (SV) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Angiox : EPAR - Product Information
English (EN) (1.09 MB - PDF)
First published: Last updated:
български (BG) (2.07 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
español (ES) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
čeština (CS) (1.72 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
dansk (DA) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Deutsch (DE) (1.16 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
eesti keel (ET) (1.06 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
ελληνικά (EL) (2.07 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
français (FR) (1.2 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
hrvatski (HR) (1.18 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
íslenska (IS) (1.11 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
italiano (IT) (1.25 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
latviešu valoda (LV) (1.74 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
lietuvių kalba (LT) (1.24 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
magyar (HU) (1.7 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Malti (MT) (1.73 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Nederlands (NL) (1.2 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
norsk (NO) (1.08 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
polski (PL) (1.75 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
português (PT) (1.08 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
română (RO) (1.25 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenčina (SK) (1.73 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
slovenščina (SL) (1.67 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
Suomi (FI) (1.14 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
svenska (SV) (1.09 MB - PDF)
First published: 02/09/2009Last updated: 14/09/2018
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)
First published: Last updated:
български (BG) (554.21 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
español (ES) (461.5 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
čeština (CS) (514.49 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
dansk (DA) (461.68 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Deutsch (DE) (461.83 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
eesti keel (ET) (461.5 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
ελληνικά (EL) (519.73 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
français (FR) (461.79 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
íslenska (IS) (482.08 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
italiano (IT) (461.47 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
latviešu valoda (LV) (518.88 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
lietuvių kalba (LT) (501.71 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
magyar (HU) (474.27 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Malti (MT) (563.32 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Nederlands (NL) (461.6 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
norsk (NO) (481.92 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
polski (PL) (519.73 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
português (PT) (461.48 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
română (RO) (546.18 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
slovenčina (SK) (514.24 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
slovenščina (SL) (490.49 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Suomi (FI) (461.65 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
svenska (SV) (461.91 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Angiox : EPAR - All Authorised presentations
English (EN) (465.02 KB - PDF)
First published: Last updated:
български (BG) (554.21 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
español (ES) (461.5 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
čeština (CS) (514.49 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
dansk (DA) (461.68 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Deutsch (DE) (461.83 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
eesti keel (ET) (461.5 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
ελληνικά (EL) (519.73 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
français (FR) (461.79 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
íslenska (IS) (482.08 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
italiano (IT) (461.47 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
latviešu valoda (LV) (518.88 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
lietuvių kalba (LT) (501.71 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
magyar (HU) (474.27 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Malti (MT) (563.32 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Nederlands (NL) (461.6 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
norsk (NO) (481.92 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
polski (PL) (519.73 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
português (PT) (461.48 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
română (RO) (546.18 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
slovenčina (SK) (514.24 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
slovenščina (SL) (490.49 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
Suomi (FI) (461.65 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
svenska (SV) (461.91 KB - PDF)
First published: 07/12/2005Last updated: 14/09/2018
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 agentsTherapeutic 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)
First published: Last updated:
Angiox : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (973.62 KB - PDF)
First published: Last updated:
Angiox-H-C-562-P46-0025 : EPAR - Assessment Report
AdoptedReference Number: EMA/588962/2014
English (EN) (1.06 MB - PDF)
First published: Last updated:
Angiox-H-C-562-P46-0025 : EPAR - Assessment Report
AdoptedReference Number: EMA/588962/2014
English (EN) (1.06 MB - PDF)
First published: Last updated:
Angiox-H-C-562-A20-0042: EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/302474/2012
English (EN) (566.62 KB - PDF)
First published: Last updated:
Angiox-H-C-562-A20-0042: EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/302474/2012
English (EN) (566.62 KB - PDF)
First published: Last updated:
Angiox-H-C-562-II-0024 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMEA/724835/2009
English (EN) (925.33 KB - PDF)
First published: Last updated:
Angiox-H-C-562-II-0024 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMEA/724835/2009
English (EN) (925.33 KB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Angiox 22 October 2009
AdoptedReference Number: EMEA/CHMP/671740/2009
English (EN) (487.08 KB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Angiox 22 October 2009
AdoptedReference Number: EMEA/CHMP/671740/2009
English (EN) (487.08 KB - PDF)
First published: Last updated:
Angiox-H-C-562-II-08 : EPAR - Scientific Discussion - Variation
Adopted
English (EN) (831.05 KB - PDF)
First published: Last updated:
Angiox-H-C-562-II-08 : EPAR - Scientific Discussion - Variation
Adopted
English (EN) (831.05 KB - PDF)
First published: Last updated:
Angiox : EPAR - Scientific Discussion
English (EN) (1.03 MB - PDF)
First published: Last updated:
Angiox : EPAR - Procedural steps taken before authorisation
English (EN) (541.99 KB - PDF)
First published: Last updated:
Angiox : EPAR - Scientific Discussion
English (EN) (1.03 MB - PDF)
First published: Last updated:
Angiox : EPAR - Procedural steps taken before authorisation
English (EN) (541.99 KB - PDF)
First published: Last updated:
News on Angiox
More information on Angiox
Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories
Reference Number: EMA/106872/2012
English (EN) (188.14 KB - PDF)
First published: Last updated:
Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories
Reference Number: EMA/946321/2011
English (EN) (71.91 KB - PDF)
First published: Last updated:
More information on Angiox
This page was last updated on