The European Medicines Agency (EMA) has published clinical data for two further medicines on its clinical data website. This leads to the launch of the website on 20 October 2016 and is in link with the Agency’s policy on the publication of clinical data.
These are the first clinical data published supporting an application that was consequently reserved. The clinical data for Aripiprazole Mylan relate to a withdrawn application for a marketing approval for a generic product to treat schizophrenia, and to stop and treat moderate to severe manic episodes in patients with bipolar I disorder.
Palonosetron Hospira is a generic product designated to stop nausea and vomiting initiated by chemotherapy.
Both medicines have been evaluated mentioning to information available on the effectiveness and protection of their active materials present in the respective sanctioned ‘reference medicines’. For more information on generic medicines see Questions and answers on generic medicines.
In future, the Agency will publicize clinical data publication under this policy on its commercial website on a case-by-case basis only. EMA will continue to highlight the publication of new clinical data on its clinical data website.
Dated: 1st Feb 2017