Angiox
Withdrawn
This medicine's authorisation has been withdrawn
bivalirudin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 21 June 2018, the European Commission withdrew the marketing authorisation for Angiox (bivalirudin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, The Medicines Company UK Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Angiox was granted marketing authorisation in the EU on 20 September 2004 and was 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 was 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 was to be administered with acetylsalicylic acid and clopidogrel. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2009. It was then granted unlimited validity in 2014.
The European Public Assessment Report (EPAR) for Angiox is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
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.
Assessment history
News on Angiox
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