Laboratoires Servier

This sponsor has funded 6 studies across 21 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
9117 Finalised EU RMP category 1 European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance Yes Yes
10039 Finalised EU RMP category 3 HLA alleles as genetic risk factors for elevation of aminotransferase levels in patients treated with agomelatine No No
10446 Finalised EU RMP category 3 Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury Yes Yes
18049 Finalised EU RMP category 1 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 EU RMP category 1 Ivabradine Drug Utilisation Study in Select European Countries: A Multinational, Retrospective, Observational Study to Assess Effectiveness of... Yes Yes
33865 Ongoing EU RMP category 3 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.