Approval · Notice of Compliance 38384 · 2026
CAPVAXIVE: Notice of Compliance 38384
Issued September 29, 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
- 38384
- Date
- September 29, 2026
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes (3, 6A, 6C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in: • children and adolescents 2 to less than 18 years of age who are at increased risk for pneumococcal disease and who have previously completed a primary pneumococcal vaccination regimen.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CAPVAXIVE | Not yet assigned | — |
Medicinal ingredients
- CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 65 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 4 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 33F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 16F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 24F 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 35B 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23A 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23B 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 31 4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE DEOAC15B 4 MCG per 0.5ML