Approval · Notice of Compliance 12357 · 2010
BOOSTRIX: Notice of Compliance 12357
Issued December 10, 2010
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
- 12357
- Date
- December 10, 2010
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional manufacturing facility
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOOSTRIX | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID 2 UNIT per 0.5ML
- TETANUS TOXOID 20 UNIT per 0.5ML
- PERTUSSIS TOXOID 8 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 8 MCG per 0.5ML
- PERTACTIN 2.5 MCG per 0.5ML