Kyowa Kirin

This sponsor has funded 7 studies across 26 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
12598 Finalised EU RMP category 3 An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations Yes Yes
12669 Finalised EU RMP category 3 An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated with Opioids... Yes Yes
23610 Finalised Not included in RMP Open label, multinational, multicentre, prospective, real world observational study of Naloxegol for patients with cancer pain diagnosed with Opioid... Yes Yes
31436 Planned EU RMP category 2 Post-authorisation safety study of allogeneic haematopoietic cell transplantation in patients treated with mogamulizumab No No
32190 Ongoing EU RMP category 3 Non-interventional Post-Authorisation Safety Study of Burosumab in the Treatment of Children >1 year of age, Adolescents and Adults with inked... Yes No
32590 Finalised Not included in RMP X-Linked Hypophosphatemia (XLH) Life Course Analysis: A Retrospective Cross-Sectional Study No No
44133 Planned Not included in RMP A national register based study examining the prevalence, comorbidities, healthcare resource utilisation and burden of illness of hereditary... No No

PAS by Risk Management Plan (RMP) requirement

Kyowa Kirin

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.