A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)

16/01/2024
05/06/2025
EU PAS number:
EUPAS108728
Study
Planned
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Documents
Study protocol
Initial protocol

AZ SLE anifrolumab pregnancy PASS_Protocol v3.0_28Aug2023_redacted

English (2.4 MB - PDF) View document
Updated protocol

AZ SLE anifrolumab pregnancy PASS_Protocol_v5.0_17Oct2024_redacted

First published: 17/03/2025
English (2.59 MB - PDF) View document
Study results
Study report
Other information