Approval · Notice of Compliance 18233 · 2016
RIXUBIS: Notice of Compliance 18233
Issued July 5, 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
- 18233
- Date
- July 5, 2016
- Company
- Baxalta Canada CorporationToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- RIXUBIS IS INDICATED IN ADULTS AND CHILDREN WITH HEMOPHILIA B (CONGENITAL FACTOR IX DEFICIENCY OR cHRISTMANS DISEASE) FOR: CONTROL OF BLEEDING EPISODES, PERIOPERATIVE MANAGEMENT, ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RIXUBIS | Not yet assigned | — |
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