Angiox

RSS

bivalirudin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/09/2018

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
115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom

Product information

25/10/2016 Angiox - EMEA/H/C/000562 - EMEA/H/C/000562/IB/0070

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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