Medicine data: periodic safety update report (PSUR) single assessments
Description
List of major changes made to the authorisation of medicines, which have been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to improve safety for patients.
EMA's scientific committees (PRAC and CHMP) and the CMDh together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the marketing authorisation.
EMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicines, together with the outcomes of assessments that lead to a variation of marketing authorisations.
Resources
| Name |
Format |
Description |
Link |
|
21 |
|
https://www.ema.europa.eu/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_document-psusa |
|
54 |
|
https://www.ema.europa.eu/sites/default/files/Medicines_output_periodic_safety_update_report_single_assessments.xlsx |
Tags
- authorised-medicine
- safety-information