ABRYSVO (Pfizer Australia Pty Ltd)
Product name
ABRYSVO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 (255 working days)
Active ingredients
recombinant respiratory syncytial virus pre-fusion F protein, water for injections
Registration type
NCE/NBE
Indication
ABRYSVO is indicated for:
- Active immunisation of pregnant women between 24-36 weeks of gestation forprevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV)in infants from birth through 6 months of age.
- Active immunisation of individuals 60 years of age and above for prevention of lowerrespiratory tract disease caused by respiratory syncytial virus (RSV).
ABRYSVO should be used in accordance with official recommendations.