Approval · Notice of Compliance 26378 · 2021
BOOSTRIX: Notice of Compliance 26378
Issued August 5, 2021
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
- 26378
- Date
- August 5, 2021
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication : BOOSTRIX (combined diphtheria, tetanus, acellular pertussis (adsorbed) vaccine) is indicated for: ¿ Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards; ¿ Passive protection against pertussis in early infancy following maternal immunisation during pregnancy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOOSTRIX | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID ADSORBED 2.5 LF per 0.5ML
- TETANUS TOXOID ADSORBED 5 LF per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ ADSORBED 8 MCG per 0.5ML
- PERTUSSIS TOXOID ADSORBED 8 MCG per 0.5ML
- PERTUSSIS TOXOID ADSORBED 2.5 MCG per 0.5ML