Baxalta

This sponsor has funded 9 studies across 24 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5798 Finalised EU RMP category 3 Pregnancy Registry to collect Long-Term Safety Data from Women treated with HyQvia Yes Yes
5812 Finalised EU RMP category 1 Non-Interventional Post-Authorization Safety Study on the Long-Term Safety of HyQvia in Subjects Treated with HyQvia (161302) Yes Yes
6691 Finalised Not included in RMP 091301: FEIBA NF GLOBAL OUTCOME STUDY (FEIBA-GO) (091301: FEIBA-GO) Yes Yes
7331 Finalised EU RMP category 2 ADVATE 2 mL (reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY (ADVATE 2 mL PASS) Yes Yes
9847 Finalised Unspecified Post Authorization Rixubis Study (PARIXS) Yes Yes
16055 Finalised EU RMP category 2 241501: Prospective and retrospective, non-interventional study to evaluate the safety and effectiveness of Obizur in real-life practice Yes Yes
21523 Finalised EU RMP category 3 Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global) Yes Yes
35698 Ongoing EU RMP category 1 TAK-660-403: Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients... No No
36659 Finalised EU RMP category 3 241302: POST-MARKETING non-interventional safety evaluation of obizur in the treatment of bleeding episodes for patients with acquired hemophilia A... Yes Yes

PAS by Risk Management Plan (RMP) requirement

Baxalta

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.