1 February 2017 - First publication of clinical data corresponding to a withdrawn application.
The EMA has published clinical data for two additional medicines on its clinical data websiteExternal link icon. This follows the launch of the website on 20 October 2016 and is in line with the Agency’s policy on the publication of clinical data.
The clinical data for Aripiprazole Mylan correspond to a withdrawn application for a marketing authorisation for a generic product to treat schizophrenia, and to prevent and treat moderate to severe manic episodes in patients with bipolar I disorder. These are the first clinical data published supporting an application that was subsequently withdrawn.
Palonosetron Hospira is a generic product indicated to prevent nausea and vomiting caused by chemotherapy.