Approval · Notice of Compliance 16778 · 2015
BOOSTRIX-POLIO: Notice of Compliance 16778
Issued April 8, 2015
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
- 16778
- Date
- April 8, 2015
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of manufacturing facility
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOOSTRIX-POLIO | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID ADSORBED 2.5 LF per 0.5ML
- TETANUS TOXOID ADSORBED 5 LF per 0.5ML
- INACTIVATED POLIOVIRUS TYPE I 40 D per 0.5ML
- INACTIVATED POLIOVIRUS TYPE II 8 D per 0.5ML
- INACTIVATED POLIOVIRUS TYPE III 32 D per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ ADSORBED 8 MCG per 0.5ML
- PERTACTIN ADSORBED 2.5 MCG per 0.5ML
- PERTUSSIS TOXOID ADSORBED 8 MCG per 0.5ML