First publication of clinical data corresponding to a withdrawn application
The European Medicines Agency (EMA) has published clinical data for two additional medicines on its clinical data website. 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The clinical data for Aripiprazole Mylan correspond to a withdrawn application for amarketing authorisation for a generic product to treat schizophrenia, and to prevent and treat moderate to severe manic episodes in patients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 These are the first clinical data published supporting an application that was subsequently withdrawn.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.
Both medicines have been assessed referring to information available on the efficacy and safety of their active substances present in the respective authorised ‘reference medicines’. For more information on generic medicines see Questions and answers on generic medicines.
In future, the Agency will announce clinical data publication under this policy on its corporate website on a case-by-case basis only. EMA will continue to highlight the publication of new clinical data on its clinical data website.