Refludan
Withdrawn
This medicine's authorisation has been withdrawn
lepirudin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 13 March 1997 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Refludan (lepirudin). Refludan was approved for anticoagulation in adult patients with heparin-induced thrombocytopenia (HAT) type II and thromboembolic disease mandating parenteral antithrombotic therapy. The marketing authorisation holder (MAH) responsible for Refludan was Celgene Europe Ltd. The European Commission was notified by 3 letters dated 31 March 2012, 2 April 2012 and 30 April 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Refludan for commercial reasons.
On 24 April 2012 the European Commission issued a decision to withdraw the marketing authorisation for Refludan. Pursuant to this decision the European Public Assessment Report for Refludan is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:T/0038
24/04/2012
This medicine’s product information is available in all official EU languages.
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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
- Refludan
- Active substance
- lepirudin
- International non-proprietary name (INN) or common name
- lepirudin
- Therapeutic area (MeSH)
- Thromboembolism
- Thrombocytopenia
- Anatomical therapeutic chemical (ATC) code
- B01AE02
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic 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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