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Novartis withdraws Aflunov application

The European Medicines Agency (EMEA) has revealed that Novartis Vaccines and Diagnostics has withdrawn a marketing application for its vaccination, Aflunov
The European Medicines Agency (EMEA) has revealed that Novartis Vaccines and Diagnostics has withdrawn a marketing application for its vaccination, Aflunov.

It has been developed as a pre-pandemic to protect people against infection from H5N1, the deadly strain of avian influenza and Novartis originally filed for centralised marketing authorisation for the drug in November 2006.

The Committee for Medicinal Products for Human use (CHMP) was conducting a review of the application at the time of the withdrawal. EMEA claims that Novartis said it was unable to provide the CHMP with further data requested in the time frame specified.

The EMEA said in a statement: "The CHMP has requested additional data because a good clinical practice (GCP) inspection showed that the main study had not been conducted in compliance with GCP, so that its results could not be considered reliable for use in evaluation of the vaccine."

Further information about the withdrawal of the drug will be published after a CHMP meeting later this month.

16th June 2008

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