Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated with Mayzent (siponimod): An OTIS Observational Pregnancy Surveillance Study

First published 21/06/2021

Last updated 18/07/2024

EU PAS number:

EUPAS41495

Study

Ongoing

Documents

Study protocol

Initial protocol

BAF312A2403 - final draft 3 protocol - for submission - Clean version_Redacted

English (1.05 MB - PDF)View document

Updated protocol

BAF312A2403 - final protocol V1.1 - for submission - Clean_Redacted

First published: 22/02/2024

English (940.31 KB - PDF)View document

Study results

Study report

Other information

ENCePP Seal

ENCePP Seal documents

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