Outcomes of single assessments of periodic safety update reports for active substances of nationally authorised medicines are available online

Outcomes of single assessments of periodic safety update reports for active substances of nationally authorised medicines are available online

The European Medicines Agency (EMA) informs that from 6 July 2015 EMA has started to publish the outcomes of single assessments of periodic safety update reports (PSURs) for active substances contained only in nationally authorised medicines. All pharmaceutical companies holding marketing authorisations for medicines at national level are advised to regularly monitor the published information to check for outcomes relevant to their products and make necessary actions according to the outcomes of single assessments.

PSURs are reports providing a regular evaluation of the benefit-risk balance of a medicine following authorisation, which marketing-authorisation holders submit at regular intervals to the competent medicines regulatory authority in the European Union as long as a medicine is available on the market. A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances.

Outcomes of single assessments of PSURs published by EMA are also available on the website of the State Agency of Medicines in the section ”Outcomes of single assessments of periodic safety update reports (PSURs)”.

Additional information is available on the EMA website.