Agence nationale de sécurité du médicament et des produits de santé (ANSM)

This sponsor has funded 12 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
5356 Finalised Veinotonics in pregnancy: a comparative study in the EFEMERIS database No No
5359 Finalised Safety of influenza AH1N1 pandemic vaccination during pregnancy: a comparative study using the EFEMERIS database No No
5362 Finalised Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a study in EFEMERIS database No No
6769 Finalised Study of Acute Liver Transplant-III: Prospective study of drug-exposed acute liver failure (ALF) in European liver transplant centers (SALT-III) No No
7994 Finalised Asthma medication during pregnancy : a cohort study in EFEMERIS No No
8976 Ongoing TRiptan Use and serious vascular events in Elderly over 65 years (TRUE) No No
24364 Ongoing Monitoring prEscription druG Abuse using DOctor Shopping bEhavior (MEGADOSE) No No
26319 Planned Domperidone Use and Misuse in Parkinson Disease (DUMP) No No
26684 Finalised Antidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort No No
29076 Ongoing Quality of asthma treatment in children and adolescents (QUAST) No No
48070 Finalised Risk of suicide attempt and suicide associated with benzodiazepine: a nationwide case crossover study (R.SUB) Yes No
48277 Ongoing Statins and the risk of adrenal insufficiency: a nested case-control study (R.USTESE) No No

PAS by Risk Management Plan (RMP) requirement

Agence nationale de sécurité du médicament et des produits de santé (ANSM)

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.