Angiox
bivalirudin
Table of contents
Overview
The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.
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 | |
Product information
25/10/2016 Angiox - EMEA/H/C/000562 - EMEA/H/C/000562/IB/0070
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
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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.