Approval · Notice of Compliance 31283 · 2023
PREVNAR 20: Notice of Compliance 31283
Issued July 21, 2023
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
- 31283
- Date
- July 21, 2023
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New Indication: Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is indicated for active immunization of infants, children and adolescents from 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREVNAR 20 | Not yet assigned | — |
Medicinal ingredients
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4.4 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2.2 MCG per 0.5ML
- CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 51 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 2.2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 2.2 MCG per 0.5ML