Approval · Notice of Compliance 19329 · 2017
IBRANCE: Notice of Compliance 19329
Issued May 19, 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
- 19329
- Date
- May 19, 2017
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indicaiton: in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive human epidermal growth factor receptor 2 (her2)-negative locally advance or metastatic breast cancer whose disease progressed after prior endocrine therapy. pre or perimenopausal women must also be treated with a luteinizing hormone releasing hormone (lhrh) agonist
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