Approval · Notice of Compliance 9532 · 2008
SUTENT: Notice of Compliance 9532
Issued May 1, 2008
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
- 9532
- Date
- May 1, 2008
- 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 (mrcc) of clear cell histology.
- Therapeutic class
- Tyrosine kinase inhibitor, anti-tumour agent
- 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