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COVID-19 VACCINE ASTRAZENECA (AstraZeneca Pty Ltd)
Product name
COVID-19 VACCINE ASTRAZENECA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
48 (255 working days)
Active ingredients
chadox1-s
Registration type
NCE/NBE
Indication
COVID-19 VACCINE ASTRAZENECA (solution for injection) has provisional approval for the indication:
- Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
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 is dependent upon 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