Approval · Notice of Compliance 8403 · 2006
ENGERIX-B: Notice of Compliance 8403
Issued November 10, 2006
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
- 8403
- Date
- November 10, 2006
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in formulation
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ENGERIX-B | Not yet assigned | — |
Medicinal ingredients
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 20 MCG per ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG per 0.5ML