Zenapax
Withdrawn
This medicine's authorisation has been withdrawn
daclizumab
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 26 February 1999, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Zenapax (daclizumab), indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
On 22 April 2008, the marketing authorisation holder (MAH) responsible for Zenapax, Roche Registration Limited, notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for Zenapax for commercial reasons. The MAH confirmed that this decision is not related to any safety concerns with Zenapax.
On 10 June 2008, the European Commission issued a decision to withdraw the marketing authorisation for Zenapax, with effect from 1 January 2009. Pursuant to this decision, the European public assessment report (EPAR) for Zenapax is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IA/0026
23/01/2007
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
- Zenapax
- Active substance
- daclizumab
- International non-proprietary name (INN) or common name
- daclizumab
- Therapeutic area (MeSH)
- Graft Rejection
- Kidney Transplantation
- Anatomical therapeutic chemical (ATC) code
- L04AA08
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Assessment history
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