Approval · Notice of Compliance 18512 · 2016
AFINITOR: Notice of Compliance 18512
Issued September 27, 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
- 18512
- Date
- September 27, 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 post-approval commitments for the notice of compliance for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (tsc) and to update the 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 | — |
Medicinal ingredients
- EVEROLIMUS 2.5 MG per TAB
- EVEROLIMUS 5 MG per TAB
- EVEROLIMUS 10 MG per TAB
- EVEROLIMUS 7.5 MG per TAB