Overview

The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.

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Product information

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

25/10/2016

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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).

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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
Revision
22

Assessment history

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