Laboratoires Servier

This sponsor has funded 6 studies across 21 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
9117 Finalised European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance Yes Yes
10039 Finalised HLA alleles as genetic risk factors for elevation of aminotransferase levels in patients treated with agomelatine No No
10446 Finalised Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury Yes Yes
18049 Finalised Drug utilisation study, in five European countries, using cross sectional analysis, to assess the extent of prescriptions of trimetazidine for its... Yes Yes
19522 Finalised Ivabradine Drug Utilisation Study in Select European Countries: A Multinational, Retrospective, Observational Study to Assess Effectiveness of... Yes Yes
33865 Ongoing A Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective (PROMETCO) No No

PAS by Risk Management Plan (RMP) requirement

Laboratoires Servier

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.