MAH not further specified

This sponsor has funded 9 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
11081 Finalised EU RMP category 1 Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records... Yes No
11379 Finalised EU RMP category 3 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 EU RMP category 1 Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions Yes Yes
34201 Ongoing EU RMP category 1 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 EU RMP category 1 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 EU RMP category 1 A Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases (VALNAC09343) No No
37438 Finalised EU RMP category 1 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 EU RMP category 3 Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of... Yes Yes
103711 Planned EU RMP category 1 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.