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REGKIRONA (Celltrion Healthcare Australia Pty Ltd)
Product name
REGKIRONA
Date registered
Evaluation commenced
Decision date
Approval time
65 (255 working days)
Active ingredients
regdanvimab
Registration type
NCE/NBE
Indication
REGKIRONA (concentrated injection) has provisional approval for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 (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 assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration