EU Panel: Withdrawal Of Marketing Authorization For Zenapax
February 13 2009 - 9:27AM
Dow Jones News
The European Medicines Agency Friday confirmed that marketing
authorization for Zenapax, used to treat organ rejection, is being
withdrawn in the European Union.
On 26 February 1999, the European Commission granted a marketing
authorisation valid throughout the European Union for the medicinal
product Zenapax, 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 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 for Zenapax will be updated to reflect that the
marketing authorisation is no longer valid.
Regulation Web Site: http://www.emea.europa.eu
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