Approval · Notice of Compliance 17885 · 2016
IBRANCE: Notice of Compliance 17885
Issued March 16, 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
- 17885
- Date
- March 16, 2016
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- PALBOCICLIB 75 MG per CAP
- PALBOCICLIB 100 MG per CAP
- PALBOCICLIB 125 MG per CAP