Approval · Notice of Compliance 7408 · 2005
PREVNAR: Notice of Compliance 7408
Issued September 20, 2005
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
- 7408
- Date
- September 20, 2005
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing facility and new presentation
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREVNAR | Not yet assigned | — |
Medicinal ingredients
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4 MCG per 0.5ML
- CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 20 MCG per 0.5ML