Approval · Notice of Compliance 17695 · 2016
ABRAXANE: Notice of Compliance 17695
Issued January 18, 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.
- Notice number
- 17695
- Date
- January 18, 2016
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- UPDATE TO THE PRODUCT MONOGRAPH TO INCLUDE DOSE RECOMMENDATIONS FOR PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT BASED ON RECENTLY COMPLETED CLINIAL STUDIES AND A POPULATION PHARMACOKINETIC (ppk) META-ANALYSIS
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ABRAXANE | Not yet assigned | — |
Medicinal ingredients
- PACLITAXEL 100 MG per VIAL