European Post-Authorization Registry for RAVICTI® (glycerol phenylbutyrate) Oral Liquid in Partnership with the European Registry and Network for Intoxication Type Metabolic Diseases (E-IMD) (HZNP-RAV-401)

First published 16/01/2017

Last updated 02/07/2024

EU PAS number:

EUPAS17267

Study

Finalised

Documents

Study protocol

Initial protocol

V3 0_RAVICTI-EU-Registry_protocol__20161129_final-clean_incl app with redaction_Redacted_sk_Redacted_sk

English (2.7 MB - PDF)View document

Updated protocol

V5 0_RAVICTI-EU-Registry_protocol__26 Apr 2018_Final Signed_Complete_Redacted (2)

First published: 22/02/2024

English (9.18 MB - PDF)View document

Study results

HZNP-RAV-401_Synopsis

English (256.93 KB - PDF)View document

Study report

Other information

ENCePP Seal

ENCePP Seal documents

Secondary tabs