A comparative observational study to evaluate the safety and effectiveness of Xromi® (hydroxycarbamide oral solution 100mg/ml) for the prevention of vaso-occlusive complications of sickle cell disease in children under 2 years of age. [PRECISE PASS]

First published 16/12/2024

Last updated 15/05/2025

EU PAS number:

EUPAS1000000076

Study

Planned

Documents

Study protocol

Initial protocol

CONFIDENTIAL_NOVDD-001_ Xromi PRECISE PASS_ Protocol_V2.0_18Oct2024_Unsigned_Redacted_Published.pdf

English (3.8 MB - PDF)View document

Study results

Study report

Other information

ENCePP Seal

ENCePP Seal documents

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