Approval · Notice of Compliance 11300 · 2010
SUTENT: Notice of Compliance 11300
Issued April 23, 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
- 11300
- Date
- April 23, 2010
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of commitments as per the Letter of Undertaking dated July 28, 2006 and April 30, 2008 for the treatment of metastatic renal cell carcinoma (MRCC) of clear cell histology, as well as an update to the Product Monograph with overall survival data for the gastrointestinal stromal tumour indication after failure of Imatinib Mesylate treatment due to resistance or intolerance
- 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