Approval · Notice of Compliance 14011 · 2013
AFINITOR: Notice of Compliance 14011
Issued January 10, 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.
- Notice number
- 14011
- Date
- January 10, 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: The treatment of postmenopausal women with hormone receptor-positive HER2-negative advanced breast cancer in combincaitoin with exemestane after recurrence or progression following treatment with letrozole or anastrozole.
- Therapeutic class
- Antineoplastic
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