Janssen R&D

This sponsor has funded 17 studies across 40 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3590 Finalised Not included in RMP Post-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of... Yes No
16023 Finalised EU RMP category 3 A Multi-Country Prospective Multi-Drug Resistant Tuberculosis Patient Registry to Monitor Bedaquiline Safety, Utilization, and Emergence of Resistance Yes No
20065 Finalised EU RMP category 3 Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A... No No
20197 Finalised EU RMP category 3 RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden No No
20730 Finalised EU RMP category 3 RRA-17401, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Taiwan No No
20733 Finalised EU RMP category 3 RRA-12037, Risperidone breast cancer study - Sweden No No
20969 Finalised EU RMP category 3 RRA-12037, Risperidone breast cancer study - Taiwan No No
23531 Finalised EU RMP category 3 RRA-21430: Acute Pancreatitis in Patients with Type 2 Diabetes Who are New Users of Canagliflozin as Compared with New Users of Other... No Yes
23705 Finalised EU RMP category 3 Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A... No Yes
27376 Finalised EU RMP category 3 Additional Pharmacovigilance Study to Evaluate the Risks of Major Hemorrhage With the Administration of IMBRUVICA® (ibrutinib) No No
27670 Finalised EU RMP category 3 Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Below Knee Lower Extremity Amputation for Patients with Type 2... No Yes
30740 Ongoing EU RMP category 3 A Retrospective Cohort Study Using Health Administrative Claims Databases to Assess Adverse Pregnancy and Infant Outcomes in Women with Psoriasis Who... No No
36038 Finalised Not included in RMP Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine (Tramadol vs Codeine) Yes No
47585 Planned EU RMP category 3 PCSCVM003617/ A Real-World Database Study of Canagliflozin Utilization in Type 1 Diabetes Patients Over Time among European Countries No No
49218 Ongoing EU RMP category 1 A Post-authorization Safety Study to Evaluate the Safety of Multiple Myeloma Patients Treated with Ciltacabtagene Autoleucel No No
49827 Planned Non-EU RMP-only A Post-authorization Safety Study to Evaluate the Incidence of and Risk Factors for Severe and Fatal Infusion-related Reactions in Participants... No No
50031 Ongoing EU RMP category 3 Post-authorization Safety Study: Ponesimod Pregnancy Outcomes Program Utilizing Enhanced Pharmacovigilance Monitoring (POEM) No No

PAS by Risk Management Plan (RMP) requirement

Janssen R&D

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.