Approval · Notice of Compliance 16817 · 2015
RIXUBIS: Notice of Compliance 16817
Issued April 21, 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
- 16817
- Date
- April 21, 2015
- Company
- Baxalta Canada CorporationToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Coagulation factor
Products in this notice
Medicinal ingredients
- NONACOG GAMMA 250 UNIT per VIAL
- NONACOG GAMMA 500 UNIT per VIAL
- NONACOG GAMMA 1,000 UNIT per VIAL
- NONACOG GAMMA 2,000 UNIT per VIAL
- NONACOG GAMMA 3,000 UNIT per VIAL