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A Real-World Study Evaluating the Safety of Pantoprazole Sodium IV in Infants Aged 1 Month to <1 Year and Patients Aged 1 to <2 Years Using an Electronic Health Records Database from the United States

A Real-World Study Evaluating the Safety of Pantoprazole Sodium IV in Infants Aged 1 Month to <1 Year and Patients Aged 1 to <2 Years Using an Electronic Health Records Database from the United States

First published 03/02/2022

Last updated 18/09/2024

EU PAS number:

EUPAS45389

Study

Finalised

Documents

Study protocol

Initial protocol

B1791096_PROTONIX PASS PROTOCOL FINAL_12 AUG 2021

English (486.15 KB - PDF) View document

Updated protocol

Protonix PASS B1791096 Protocol Amendment 1 Clean 02-10-22

First published: 22/02/2024

English (847 KB - PDF) View document

Study results

Study report

B1791096 Non-Interventional Study Report Manuscript Signatures 23-Jun-2022.pdf

English (1.16 MB - PDF) View document

B1791096 SAP Protonix PASS_V5_01-24-2022_.pdf

English (2.76 MB - PDF) View document

Protonix PASS B1791096 Non-Interventional Study Report Abstract 23-Jun-2022_FINAL (1).pdf

English (2.45 MB - PDF) View document

Protonix PASS B1791096 Protocol Amendment 1 Clean 02-10-22.pdf

English (404.12 KB - PDF) View document

Protonix PASS B1791096_Report_23-Jun-2022_FINAL.pdf

English (13.21 MB - PDF) View document

Other information

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