A Post-Authorization Safety Study (PASS) to Characterize Safety Events and Special Conditions, Such as Pregnancy and Infant Outcomes, in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Crovalimab Within the IPIG Registry

First published 07/08/2025

Last updated 21/10/2026

EU PAS number:

EUPAS1000000702

Study

Planned

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Documents

Study protocol

Initial protocol

Prot_MO45473_crovalimab_v3,_Published_Output-1_Redacted.pdf

English (988.05 KB - PDF) View document

Updated protocol

MO45473_Protocol_v4_Redacted

First published: 28/01/2026

English (818.81 KB - 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 The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

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A Post-Authorization Safety Study (PASS) to Characterize Safety Events and Special Conditions, Such as Pregnancy and Infant Outcomes, in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Crovalimab Within the IPIG Registry

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