ApprovalTrail

Drug · DIN 02445646

FLUZONE HIGH-DOSE

INFLUENZA VIRUS VACCINE TRIVALENT TYPES A AND B (SPLIT VIRION).0.5 ML SINGLE-DOSE PREFILLED SYRINGES

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since September 10, 2025; first marketed September 27, 2016.
Drug Identification Number (DIN)
02445646
Company (DIN owner)
Sanofi Vaccines Canada Ltd.Toronto, Ontario, Canada
Schedule
Schedule d
Dosage form
Suspension
Route
Intramuscular
Therapeutic class (ATC)
Influenza, inactivated, split virus or surface antigen J07BB02
Class
Human
Record last updated
September 9, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
HAEMAGGLUTININ-STRAIN A (H3N2)60 MCG0.5 ML
HAEMAGGLUTININ-STRAIN B60 MCG0.5 ML
HAEMAGGLUTININ-STRAIN A (H1N1)60 MCG0.5 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • February 10, 2017: NOC 18954New Drug Submission (NDS) · Transfer of drug identification number
  • September 9, 2015: NOC 17262Supplement to a New Drug Submission (SNDS) · For active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults 65 years of age and older