Approval · Notice of Compliance 22033 · 2019
ENGERIX-B: Notice of Compliance 22033
Issued April 3, 2019
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
- 22033
- Date
- April 3, 2019
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new presentation and addition of new filling sites
Products in this notice
Medicinal ingredients
- HEPATITIS B SURFACE ANTIGEN 20 MCG per ML
- HEPATITIS B SURFACE ANTIGEN 10 MCG per 0.5ML