Approval · Notice of Compliance 18571 · 2016
IBRANCE: Notice of Compliance 18571
Issued October 6, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 18571
- Date
- October 6, 2016
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Post approval commtment #1 in accordance with letter of undertaking: top line summary for the confirmatory phase 3 study for use in advanced breast cancer and update to the product monograph
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IBRANCE | Not yet assigned | — |
Medicinal ingredients
- PALBOCICLIB 75 MG per CAP
- PALBOCICLIB 100 MG per CAP
- PALBOCICLIB 125 MG per CAP