Approval · Notice of Compliance 12476 · 2011
AFINITOR: Notice of Compliance 12476
Issued June 30, 2011
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
- 12476
- Date
- June 30, 2011
- 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 patients 3 years of age or older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) that have demonstrated serial growth, who are not candidates for surgical resection and for whom immediate surgical intervention is not required, at a starting dose of 2.5mg, 5mg or 7.5mg once per day
- Therapeutic class
- Antineoplastic agent (mTOR kinase inhibitor)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AFINITOR | Not yet assigned | — |
| AFINITOR | 02369257 | Marketed |
Medicinal ingredients
- EVEROLIMUS 5 MG per TAB
- EVEROLIMUS 10 MG per TAB
- EVEROLIMUS 2.5 MG per TAB