Approval · Notice of Compliance 6380 · 2005
FEMARA: Notice of Compliance 6380
Issued April 1, 2005
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
- 6380
- Date
- April 1, 2005
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: 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; antitumor 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