CSL Behring

This sponsor has funded 4 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
6040 Ongoing EU RMP category 3 Privigen® use and haemolytic anaemia in adults and children and the Privigen® safety profile in children with CIDP - an observational hospital-based... Yes No
8472 Finalised EU RMP category 3 An observational cohort study of the risk of thromboembolic events among adult patients treated with KCENTRA® compared with plasma for urgent reversal... No No
48683 Planned Not included in RMP World Federation of Hemophilia Gene Therapy Registry (WFH GTR) No No
106066 Planned EU RMP category 1 An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in... No No

PAS by Risk Management Plan (RMP) requirement

CSL Behring

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.