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MRESVIA (Moderna Australia Pty Ltd)
Product name
MRESVIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
277 (255 working days)
Active ingredients
respiratory syncytial virus F protein mRNA (nucleoside modified)
Registration type
NCE/ NBE
Indication
mRESVIA is a vaccine indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.
mRESVIA should be used in accordance with official recommendations.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available