Shionogi

This sponsor has funded 3 studies across 6 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
8585 Ongoing Safety and Incidence of Side Effects in a Cohort of Postmenopausal Women Prescribed Ospemifene Relative to Patients Diagnosed with but not Treated for... No No
40551 Ongoing Retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections... No No
43258 Planned An Observational Post-Authorisation Safety Study (PASS) of Patients with Chronic Opioid Use for Non-Cancer Pain and Cancer Pain who have... No No

PAS by Risk Management Plan (RMP) requirement

Shionogi

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.