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

Documents

Study protocol

Initial protocol

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

Updated protocol

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

First published: 22/02/2024

Study results

No information provided.

Study report

No information provided.

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

No information provided.