Approval · Notice of Compliance 14039 · 2013
AFINITOR: Notice of Compliance 14039
Issued January 25, 2013
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
- 14039
- Date
- January 25, 2013
- 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 adult patients (> 18 years of age) with renal angiomuylopipoma assoricated with tuberous sclerosis complex (TSC) aho do not require immediate surgery
- Therapeutic class
- Antineoplastic
- With conditions
- Yes (NOC/c)
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