Approval · Notice of Compliance 12686 · 2011
SYNFLORIX: Notice of Compliance 12686
Issued October 7, 2011
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
- 12686
- Date
- October 7, 2011
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a two-dose Primary Series for Infants 6 Weeks to 6 Months of age and use in Children up to 5 Years of Age
- Therapeutic class
- Active Immunizing Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SYNFLORIX | Not yet assigned | — |
Medicinal ingredients
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 1 MCG per 0.5ML