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XEVUDY (GlaxoSmithKline Australia Pty Ltd)
Product name
XEVUDY
Date registered
Evaluation commenced
Decision date
Approval time
65 (255 working days)
Active ingredients
sotrovimab
Registration type
NCE/NBE
Indication
XEVUDY (concentrated injection) has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration