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RONAPREVE (Roche Products Pty Ltd)

Product name
RONAPREVE
Sponsor
Roche Products Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
33 (255 working days)
Active ingredients
casirivimab; imdevimab
Registration type
NCE/NBE
Indication
Treatment:

RONAPREVE (solution for injection) is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.

Post-exposure prophylaxis:

RONAPREVE is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either:

  • have a medical condition making them unlikely to respond to or be protected by vaccination, OR
  • are not vaccinated against COVID-19. (refer to section 4.2 Dose and method of administration and section 5.1, Clinical Trials).

RONAPREVE is not intended to be used as a substitute for vaccination against COVID-19.

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

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