Approval · Notice of Compliance 8311 · 2006
FEMARA: Notice of Compliance 8311
Issued October 6, 2006
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
- 8311
- Date
- October 6, 2006
- 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 adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. fulfilment of commitment #1c outlined in letter of undertaking dated april 1, 2005 for the extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy
- Therapeutic class
- Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis; anti-tumour agent
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FEMARA | Not yet assigned | — |
Medicinal ingredients
- LETROZOLE 2.5 MG per TAB