Astellas Pharma

This sponsor has funded 14 studies across 28 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5529 Finalised EU RMP category 3 Post-Authorization Safety Program—Validation of the Clinical Practice Research Datalink for the Study of Cardiovascular and Neoplasm Events in Users... Yes Yes
5552 Finalised EU RMP category 3 A Multicenter, Single-arm, Open-label, Post-marketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant... No Yes
7924 Finalised EU RMP category 3 A Study of Treatments for Overactive Bladder: Incidence and Validation of Cardiovascular and Cancer Outcomes and Examination of Drug-Use Patterns in a... No Yes
8441 Finalised EU RMP category 3 Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments... Yes Yes
8444 Finalised EU RMP category 3 Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of... Yes Yes
8517 Finalised EU RMP category 3 Validation of a US Health Care Claims Database for the Study of Cardiovascular and Neoplasm Events among Users of Treatments for Overactive Bladder No Yes
9553 Finalised EU RMP category 3 Protocol for the Effectiveness Check of the Awareness and Knowledge of Educational Materials for the Eligard Risk Minimization Program Yes No
13634 Finalised EU RMP category 3 Survey to Measure the effectiveness of the Mycamine Prescriber Checklist in the European Union No No
15063 Finalised EU RMP category 3 Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland... Yes Yes
16088 Finalised EU RMP category 3 Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common... Yes Yes
16282 Finalised EU RMP category 3 Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder Yes Yes
22475 Finalised Not included in RMP A prospective, single arm, non-interventional study to evaluate the extent to which handling errors (HE) lead to Lack of Efficacy (LOE) in patients... Yes Yes
37354 Finalised EU RMP category 3 Evaluation of the Effectiveness of a Xospata Routine Risk Minimisation Measure (RMM) and an Additional Risk Minimisation Measure (aRMM): A... Yes No
104456 Planned EU RMP category 3 A Non-Interventional Post-Authorization Safety Study (NI-PASS) as an effectiveness check of a Patient Card for Padcev™ No No

PAS by Risk Management Plan (RMP) requirement

Astellas Pharma

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.