Angiox
Withdrawn
This medicine's authorisation has been withdrawn
bivalirudin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.
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
- 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
Public statement on Angiox: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/517907/2018
English (EN) (59.72 KB - PDF)
First published: Last updated:
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