MAH not further specified

This sponsor has funded 9 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
11081 Finalised Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records... Yes No
11379 Finalised Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to... No Yes
20720 Finalised Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions Yes Yes
34201 Ongoing A post-authorization safety study (PASS) to evaluate the paternal exposure to valproate and the risk of neurodevelopmental disorders including autism... Yes Yes
34465 Finalised Surveys among Health Care Professionals and Patients to assess their knowledge and behaviour with respect to the new (2018) Risk Minimization Measures... Yes Yes
34519 Planned A Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases (VALNAC09343) No No
37438 Finalised Non-Interventional retrospective longitudinal study in the UK and France to evaluate and identify the best practices for switching of valproate and... Yes No
38096 Finalised Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of... Yes Yes
103711 Planned Characterization of neurodevelopmental disorders in children exposed or unexposed in utero to valproate and/or other antiepileptic drugs with... No No

PAS by Risk Management Plan (RMP) requirement

MAH not further specified

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.