Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry (Kesimpta Pregnancy Registry)

24/11/2022
08/08/2024
EU PAS number:
EUPAS49803
Study
Ongoing
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Study protocol
Initial protocol

OMB157G2403 (main) - final protocol V1.0 - for submission_Redacted

English (1.29 MB - PDF) View document
Study results
Study report
Other information