Approval · Notice of Compliance 12469 · 2011
SUTENT: Notice of Compliance 12469
Issued June 30, 2011
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
- 12469
- Date
- June 30, 2011
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: For the treatment of patients with unresectable locally advanced or metastic, well differentiated pancreatic neuroendocrine tumours (pancreatic NET), whose disease is progressive
- Therapeutic class
- Tyrosine kinase inhibitor / Anti-tumour agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUTENT | Not yet assigned | — |
Medicinal ingredients
- SUNITINIB MALATE 12.5 MG per CAP
- SUNITINIB MALATE 25 MG per CAP
- SUNITINIB MALATE 37.5 MG per CAP
- SUNITINIB MALATE 50 MG per CAP