Approval · Notice of Compliance 8210 · 2006
SUTENT: Notice of Compliance 8210
Issued August 17, 2006
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 8210
- Date
- August 17, 2006
- 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 metastatic renal cell carcinoma of clear cell histology after failure of cytokine-based therapy or in patients who are considered likely to be intolerant of such therapy
- Therapeutic class
- Tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
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 50 MG per CAP