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)

28/06/2013
01/04/2024
EU PAS number:
EUPAS3636
Study
Finalised
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Documents
Study protocol
Initial protocol

Sobi NTBC-005 PASS Amended CSP Version 2.1 25Nov16_Redacted

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Study results
Study results

OPAL Clinical Study Report 27 Mar 2020_Redacted

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Study report
Other information