Approval · Notice of Compliance 13014 · 2012
AFINITOR: Notice of Compliance 13014
Issued February 2, 2012
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
- 13014
- Date
- February 2, 2012
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, 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 progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease
- Therapeutic class
- Antineoplastic Agent (mTOR Kinase Inhibitor)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AFINITOR | Not yet assigned | — |
Medicinal ingredients
- EVEROLIMUS 5 MG per TAB
- EVEROLIMUS 10 MG per TAB
- EVEROLIMUS 2.5 MG per TAB