Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study

03/03/2022
11/05/2026
EU PAS number:
EUPAS45972
Study
Ongoing
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Documents
Study protocol
Initial protocol

D1346R00004_Protocol V 2.0_05Nov2021_Redacted

English (359.51 KB - PDF) View document
Updated protocol

CSP redacted.pdf

First published: 30/05/2025
English (4.88 MB - PDF) View document

d1346r00004-pass-clinical-study-report_Redacted

First published: 22/02/2024
English (2.24 MB - PDF) View document
Study results
Study report
Other information