Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries

First published 10/05/2023

Last updated 09/11/2026

EU PAS number:

EUPAS104368

Study

Ongoing

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Documents

Study protocol

Updated protocol

CH-SPN-12180_PASS_Protocol_V4_Redacted.pdf

First published: 07/11/2026

English (831.02 KB - PDF) View document

232SM405 PASS Protocol V3.0 Final.pdf

First published: 09/06/2025

English (701.32 KB - PDF) View document

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 The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.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.

Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries

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