Approval · Notice of Compliance 16775 · 2015
HIBERIX: Notice of Compliance 16775
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
- 16775
- 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 |
|---|---|---|
| HIBERIX | Not yet assigned | — |
Medicinal ingredients
- TETANUS TOXOID 40 MCG per 0.5ML
- HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10 MCG per 0.5ML