The marketing authorisation for Refludan has been withdrawn at the request of the marketing-authorisation holder.
Refludan : EPAR - Summary for the public (PDF/262.17 KB)
First published: 27/04/2009
Last updated: 27/07/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celgene Europe Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
24/04/2012 Refludan - EMEA/H/C/000122 - T/0038
- 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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Anticoagulation in adult patients with heparin-induced thrombocytopenia type II and thromboembolic disease mandating parenteral antithrombotic therapy.
The diagnosis should be confirmed by the heparin-induced platelet activation assay or an equivalent test.