Approval · Notice of Compliance 12359 · 2010
TWINRIX: Notice of Compliance 12359
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
- 12359
- 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 |
|---|---|---|
| TWINRIX | Not yet assigned | — |
| TWINRIX JUNIOR | Not yet assigned | — |
Medicinal ingredients
- HEPATITIS A VACCINE, INACTIVATED 720 UNIT per 1ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 20 MCG per 1ML
- HEPATITIS A VACCINE, INACTIVATED 360 UNIT per 0.5ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG per 0.5ML