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COVID-19 VACCINE JANSSEN (Janssen-Cilag Pty Ltd)
Product name
COVID-19 VACCINE JANSSEN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
ad26.cov2.s
Registration type
NCE/NBE
Indication
COVID-19 Vaccine Janssen (suspension for injection) has provisional approval for the indication:
COVID-19 Vaccine Janssen is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 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 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