Approval · Notice of Compliance 15115 · 2014
PREVNAR 13: Notice of Compliance 15115
Issued January 10, 2014
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
- 15115
- Date
- January 10, 2014
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of the indication to include adults from 18 to 49 years of age
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREVNAR 13 | 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 34 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 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