Approval · Notice of Compliance 17515 · 2015
JAKAVI: Notice of Compliance 17515
Issued November 24, 2015
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
- 17515
- Date
- November 24, 2015
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: the control of hematocrit in adult patients with polycythemia vera (pv) resistant to or intolerant of a cytoreductive agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JAKAVI | Not yet assigned | — |
Medicinal ingredients
- RUXOLITINIB PHOSPHATE 5 MG per TAB
- RUXOLITINIB PHOSPHATE 10 MG per TAB
- RUXOLITINIB PHOSPHATE 15 MG per TAB
- RUXOLITINIB PHOSPHATE 20 MG per TAB