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

First published 16/01/2024

Last updated 05/06/2025

EU PAS number:

EUPAS108728

Study

Planned

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

ENCePP Seal

ENCePP Seal documents

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