Approval · Notice of Compliance 22069 · 2019
PREVNAR 13: Notice of Compliance 22069
Issued April 15, 2019
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
- 22069
- Date
- April 15, 2019
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of an indication: prevnar 13 is indicated for active immunization of infants and childre from 6 weeks to 5 years of age (prior to the 6th birthday) for the prevention of invasive pnemonococcal disease (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia) and acute otitis media caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREVNAR 13 | Not yet assigned | — |
Medicinal ingredients
- CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 34 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 1 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 3 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 4 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 5 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 6A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 6B 4.4 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 7F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 9V 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 14 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 18C 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 19A 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 19F 2.2 MCG per 0.5ML
- PNEUMOCOCCAL CONJUGATE SEROTYPE 23F 2.2 MCG per 0.5ML