Approval · Notice of Compliance 17889 · 2016
SYNFLORIX: Notice of Compliance 17889
Issued March 18, 2016
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
- 17889
- Date
- March 18, 2016
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- EXTENSION OF INDICATION: fOR ACTIVE IMMUNIZATION OF INFANTS AND CHILDREN FROM 6 WEEKS UP TO 5T YEARS AGAINST STREPTOCOCCUS PNEUMONIAE SEROTYPES 1,4,5,6B,7F,9V,14,18C,19F,23F CRESS-REACTIVE SEROTYPE 19a, AND INVASIVE DISEASE CAUSED BY THESE SEROTYPES (INCLUDING SEPSIS, MENINGITIS, BACTERAIEMIC PNEUMONIA, PLEURAL EMPYEMA AND BACTERAEMIA
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