PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. EMA carries out PSUSA procedures to assess PSURs of …

2025年1月17日 · Metformin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002001/202404

Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : List of nationally authorised medicinal products - PSUSA/00010649/202302 Reference Number: …

Changes to product information following the outcome of PSUSA procedures (PSUR single assessment) can be found on: for centrally authorised products (CAPs) - a Decision will be …

The Public Safety Unmanned Systems Academy (PSUSA) is a Texas registered nonprofit dedicated to providing comprehensive unmanned systems solutions for agencies, …

Published results from PSUSA NAP (MRP + NP) can be searched by substance name and category or procedure number on the EMA’s website as follows: Categories – Human …

The PSUSA is a safety report required by the European Medicines Agency (EMA) for all human medicines from marketing authorisation holders. It includes information on the product’s safety …

We're thrilled to welcome you – whether you’re a church member, leader, or someone curious about faith. Find inspiration and resources that support PC(USA) communities and deepen …

CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) (November 2024) [Track version]

2016年10月26日 · The European Medicines Agency (EMA) has published a new search page on its website, helping users to find the outcomes of PSUSA procedures for active substances or …