Approval · Notice of Compliance 14907 · 2013
GARDASIL: Notice of Compliance 14907
Issued November 15, 2013
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
- 14907
- Date
- November 15, 2013
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in manufacturing - new facility
- 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