Approval · Notice of Compliance 20056 · 2017
IBRANCE: Notice of Compliance 20056
Issued November 17, 2017
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
- 20056
- Date
- November 17, 2017
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of the final Post-Approval Commitment for the Notice of Compliance with conditions for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IBRANCE | Not yet assigned | — |
Medicinal ingredients
- PALBOCICLIB 75 MG per TAB
- PALBOCICLIB 100 MG per TAB
- PALBOCICLIB 125 MG per TAB