Angiox

bivalirudin

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The marketing authorisation for Angiox has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Angiox : EPAR - Summary for the public BG = bălgarski 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public ES = español 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public CS = čeština 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public DA = dansk 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public DE = Deutsch 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public ET = eesti keel 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public EL = elliniká 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public EN = English 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public FR = français 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public IT = italiano 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public LV = latviešu valoda 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public LT = lietuvių kalba 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public HU = magyar 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public MT = Malti 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public NL = Nederlands 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public PL = polski 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public PT = português 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public RO = română 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public SK = slovenčina 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public SL = slovenščina 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public FI = suomi 2009-09-02 2018-09-14
Angiox : EPAR - Summary for the public SV = svenska 2009-09-02 2018-09-14

This EPAR was last updated on 14/09/2018 .

Authorisation details

Product details

Product details for Angiox
NameAngiox
Agency product numberEMEA/H/C/000562
Active substance

bivalirudin

International non-proprietary name (INN) or common name

bivalirudin

Therapeutic area Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code B01AE06

Publication details

Publication details for Angiox
Marketing-authorisation holder

The Medicines Company UK Ltd

Revision22
Date of issue of marketing authorisation valid throughout the European Union20/09/2004

Contact address:

The Medicines Company UK Ltd
115 L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14
Angiox : EPAR - Product Information SV = svenska 2009-09-02 2018-09-14

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - All Authorised presentations SV = svenska 2005-12-07 2018-09-14

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Angiox : EPAR - Procedural steps taken before authorisation SV = svenska 2005-12-07 2018-09-14
Angiox : EPAR - Scientific Discussion SV = svenska 2005-12-07 2018-09-14