Refludan

RSS

lepirudin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Refludan has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 27/07/2012

Authorisation details

Product details
Name
Refludan
Agency product number
EMEA/H/C/000122
Active substance
lepirudin
International non-proprietary name (INN) or common name
lepirudin
Therapeutic area (MeSH)
  • Thromboembolism
  • Thrombocytopenia
Anatomical therapeutic chemical (ATC) code
B01AE02
Publication details
Marketing-authorisation holder
Celgene Europe Ltd.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
13/03/1997
Contact address
Riverside House
Riverside Walk
Windsor
Berkshire
SL4 1NA
United Kingdom

Product information

24/04/2012 Refludan - EMEA/H/C/000122 - T/0038

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.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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.

Assessment history

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