The European Medicines Agency (EMA) has published today 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.
Armisarte is a hybrid product, meaning it is similar to its reference product but is available in a different pharmaceutical form. It is indicated for the treatment of malignant pleural mesothelioma lung cancer and advanced non-small-cell lung cancer.
Caspofungin Accord is a generic product indicated for the treatment of invasive candidiasis, invasive aspergillosis and other suspected fungal infections when the patient is febrile and neutropenic.
The clinical data available for both medicines are the clinical overviews (module 2.5 of the common technical document), as both medicines have been authorised referring to an existing medicine and are administered by infusion. For more information on generic medicines see Questions and answers on generic medicines.
Today’s publication adds to the clinical data for Kyprolis and Zurampic, published on 20 October 2016. Since the launch of the new website, 1017 general users and 234 academic users have registered. Documents have been viewed 4,486 times and downloaded 16,570 times, giving an average of around 129 views and 476 downloads per calendar day.
The Agency intends to publish clinical data on a monthly basis until routine publishing timelines are achieved.