Approval · Notice of Compliance 13042 · 2012
ADVATE: Notice of Compliance 13042
Issued February 15, 2012
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
- 13042
- Date
- February 15, 2012
- Company
- Baxter Healthcare CorporationDeerfield, Illinois, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with Haemophilia A
- Therapeutic class
- Coagulation Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVATE | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3,000 UNIT per VIAL