Approval · Notice of Compliance 13595 · 2012
CERVARIX: Notice of Compliance 13595
Issued August 29, 2012
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
- 13595
- Date
- August 29, 2012
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change to age of indication, extension of post-immunization immunogenicity data
- Therapeutic class
- Active Immunizing Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CERVARIX | Not yet assigned | — |
Medicinal ingredients
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN 20 MCG per 0.5ML
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN 20 MCG per 0.5ML