Post-Authorization Safety Study (PASS) of conjugated estrogens/bazedoxifene (CE/BZA) in the United States

First published 17/11/2015

Last updated 22/02/2024

EU PAS number:

EUPAS11599

Study

Finalised

Documents

Study protocol

Initial protocol

B2311060_Duavive US PASS FINAL Protocol CHMP ENDORSED 22OCT2015

English (1001.1 KB - PDF)View document

Updated protocol

B2311060_Duavive US PASS FINAL Protocol CHMP ENDORSED 22OCT2015 AMENDED 21AUG2019_FINAL_clean (w-approval record)

First published: 22/02/2024

English (7.21 MB - PDF)View document

Study results

Duavive_B2311060_Final_Report_Abstract_fv

English (1.75 MB - PDF)View document

Study report

Duavive_B2311060_Final_Report_fv

English (4.22 MB - PDF)View document

Other information

ENCePP Seal

ENCePP Seal documents

Signed checklist for study protocols

ENCEPP Protocol Checklist US PASS B2311060 SIGNED SUBMITTED 26JAN2015

English (1.54 MB - PDF)View document

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