Approval · Notice of Compliance 18081 · 2016
AFINITOR: Notice of Compliance 18081
Issued April 29, 2016
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
- 18081
- Date
- April 29, 2016
- 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
- Fulfilment of the final post-approval commitment for the notice of compliance with conditions for the treatment of subependymal giant cell astrocytoma associated with tuberous sclerosis complex, and to update pertinent sections of the product monograph with long-term safety and efficacy data
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AFINITOR | Not yet assigned | — |
| AFINITOR DISPERZ | Not yet assigned | — |
Medicinal ingredients
- EVEROLIMUS 2.5 MG per TAB
- EVEROLIMUS 5 MG per TAB
- EVEROLIMUS 10 MG per TAB
- EVEROLIMUS 7.5 MG per TAB
- EVEROLIMUS 2 MG per TAB
- EVEROLIMUS 3 MG per TAB