Pregnancy and Infant Outcomes Following Exposure to PAXLOVID: A Post-Authorization Safety Study

First published 24/08/2023

Last updated 19/03/2025

EU PAS number:

EUPAS106321

Study

Ongoing

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Documents

Study protocol

Initial protocol

C4671038_PROTOCOL_V1_22JUN2023

English (1.25 MB - PDF)View document

Updated protocol

C4671038_PROTOCOL AMENDMENT 3_20NOV2024.pdf

First published: 18/03/2025

English (1.58 MB - PDF)View document

Study results

Study report

Other information

Study, other information

C4671038_PROTOCOL_V1_02NOV2023.pdf

English (1.21 MB - PDF)View document

ENCePP Seal

ENCePP Seal documents