EMEA public statement on the market withdrawal of Daclizumab (Zenapax)

Daclizumab (Zenapax), a monoclonal antibody to the alpha subunit of the IL-2 receptor of T cells, has been withdrawn from the market in the European Union since Since 1 January 2009. According to an EMEA press release issued 16 January 2009:

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 27 November 2006, 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the European public assessment report (EPAR) for Zenapax will be updated to reflect that the marketing authorisation is no longer valid.

Source: Public statement on Zenapax (daclizumab) Withdrawal of the marketing authorisation in the European Union. PDF full text

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