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

24/08/2023
02/09/2025
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 4_18JUNE2025.pdf

First published: 11/08/2025
English (1.57 MB - PDF) View document

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