Periodic Assessment Survey of Patients/Caregivers to Assess Understanding of the Risks with the BKEMV® Risk Evaluation and Mitigation Strategy (REMS)

First published 03/02/2025

Last updated 07/09/2026

EU PAS number:

EUPAS1000000368

Study

Ongoing

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Documents

Study protocol

Initial protocol

Protocol-Published Original eculizumab biosimilar 20240214 .pdf

English (796.41 KB - PDF) View document

Updated protocol

Protocol-Published Amendment eculizumab biosimilar 20240214 1 .pdf

First published: 01/09/2026

English (1.14 MB - PDF) View document

Study results

No information provided.

Study report

No information provided.

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

No information provided.

Periodic Assessment Survey of Patients/Caregivers to Assess Understanding of the Risks with the BKEMV® Risk Evaluation and Mitigation Strategy (REMS)

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