A non-interventional Post Authorization Safety Study (PASS) to evaluate long-term safety of Orfadin treatment in hypertyrosinemia type 1 (HT-1) patients in standard clinical care (OPAL)

First published 28/06/2013

Last updated 01/04/2024

EU PAS number:

EUPAS3636

Study

Finalised

Documents

Study protocol

Initial protocol

Sobi NTBC-005 PASS Amended CSP Version 2.1 25Nov16_Redacted

English (385.43 KB - PDF)View document

Study results

OPAL Clinical Study Report 27 Mar 2020_Redacted

English (2.98 MB - PDF)View document

Study report

Other information

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