ApprovalTrail

Approval · Notice of Compliance 36731 · 2026

MRESVIA: Notice of Compliance 36731

Issued January 14, 2026

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
36731
Date
January 14, 2026
Company
Moderna Biopharma Canada CorporationToronto, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Expansion of Indication : mRESVIA (Respiratory Syncytial Virus (RSV) mRNA Vaccine) is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • adults 60 years of age and older; • adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

Products in this notice

BrandDINStatus today
MRESVIANot yet assigned—

Medicinal ingredients