NeLM news service
EMEA publishes questions and answers on the withdrawal of application for a change to the marketing authorisation for aripiprazole (Abilify™)

Source: EMEA

Date published: 06/01/2010 15:34

Summary
by: Sheetal Ladva

The EMEA has published a questions and answers document explaining the reasons behind the withdrawal of the application for a new indication for aripiprazole (Abilify™) in the treatment of resistant major depressive episodes.

 

The withdrawal was based on the Committee for Medicinal Products for Human Use (CHMP) consideration that there were insufficient long term data to support this indication.

 

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