Astellas Pharma Europe

This sponsor has funded 9 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2857 Finalised EU RMP category 2 A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents (MYCOS) Yes Yes
4357 Finalised EU RMP category 3 Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids (JOELLE) Yes No
9507 Finalised Not included in RMP A drug utilisation study (DUS) of the use of oral fidaxomicin in the routine clinical setting (2819-CL- 2002) (Anemone) No Yes
34255 Finalised EU RMP category 3 Non-Interventional Post-Authorisation Safety Study (NI-PASS) as an effectiveness check of an additional Risk Minimisation Measure (aRMM) (Direct... Yes No
35011 Finalised EU RMP category 3 A Non-interventional Post-authorisation Safety Study (PASS) as an Effectiveness Check of the Prescriber Checklist for Mycamine® (micafungin) Yes Yes
37025 Finalised EU RMP category 3 A non-interventional post-authorization safety study (NI-PASS) of outcomes associated with the use of tacrolimus around conception, or during... Yes No
104771 Ongoing Not included in RMP An Observational Study to Compare cardiovascular related hospitalization in chemo-naïve Patients with Metastatic Castration Resistant Prostate Cancer,... No No
105591 Planned Not included in RMP Real-world use of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with... No No
107848 Planned Not included in RMP Enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and... No No

PAS by Risk Management Plan (RMP) requirement

Astellas Pharma Europe

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.