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NUVAXOVID-SARS-CoV-2 rS (NVX-CoV2373) (Biocelect Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
61 (255 working days)
Active ingredients
SARS-CoV-2 rS (NVX-CoV2373)
Registration type

NUVAXOVID has provisional approval for the indication:

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short-term efficacy and safety data. Continued approval 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

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