European Commission (EC)

This sponsor has funded 7 studies across 57 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
1974 Ongoing Not included in RMP Pharmacovigilance In Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents And/Or Methotrexate. A Pediatric Rheumatology International... Yes No
5064 Finalised Not included in RMP European Clinical Study for the Application of Regenerative Heart Valves – ESPOIR (the “Surveillance”) Yes Yes
10201 Finalised Not included in RMP Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the “Surveillance”) Yes Yes
25373 Finalised Not included in RMP Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice Yes Yes
39679 Planned Not included in RMP COVID-19 vaccine effectiveness at primary care level in Europe: generic protocol (I-MOVE-COVID primary care VE) Yes No
39683 Planned Not included in RMP European study of COVID-19 vaccine effectiveness against hospitalised SARI patients laboratory-confirmed with SARS-CoV-2 (I-MOVE-COVID VE hospital... No No
107315 Ongoing Not included in RMP EHDS2 Pilot Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 during the Omicron period. Yes No

PAS by Risk Management Plan (RMP) requirement

European Commission (EC)

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.