Approval · Notice of Compliance 11080 · 2010
GARDASIL: Notice of Compliance 11080
Issued February 22, 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
- 11080
- Date
- February 22, 2010
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GARDASIL | Not yet assigned | — |
Medicinal ingredients
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN 20 MCG per 0.5ML
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN 40 MCG per 0.5ML
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN 40 MCG per 0.5ML
- RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN 20 MCG per 0.5ML