Eli Lilly Japan

This sponsor has funded 11 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
8663 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly... Yes No
9786 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS,... Yes No
26442 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients with type 2 Diabetes Mellitus... No No
44340 Ongoing Non-EU RMP-only Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients with chronic heart failure in Japan (PMS of JARDIANCE in CHF) No No
48504 Ongoing Non-EU RMP-only An Observational Cohort Study to Investigate the Risk of Serious Infections Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV)... No No
48903 Ongoing Non-EU RMP-only An Observational Cohort Study to Investigate the Risk of Malignancies Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV)... No No
104412 Planned Non-EU RMP-only A Post-marketing Safety Study to Investigate the Risk of Serious CV Events among Galcanezumab (Emgality®) Users Using the Japan Medical Data Center... No No
104508 Planned Non-EU RMP-only A cohort study to investigate the risk of severe hypoglycemia among diabetic patients treated with Lyumjev® using the Medical Data Vision (MDV)... No No
104511 Planned Non-EU RMP-only An observational cohort study to investigate the risk factors for interstitial lung disease (ILD) among breast cancer patients treated with... No No
106059 Planned Not included in RMP Tirzepatide (Mounjaro®) Benefit for EArly glycemic and weight managemenT in patients with type 2 diabetes vs. oral semaglutide (Rybelsus®) in real... No No
106766 Planned Non-EU RMP-only A Post Marketing Safety Study of Lasmiditan (REYVOW®) to describe the use in pregnant women and pregnancy outcomes using the Japan Medical Data Center... No No

PAS by Risk Management Plan (RMP) requirement

Eli Lilly Japan

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.