Approval · Notice of Compliance 6003 · 2004
RECOMBINATE: Notice of Compliance 6003
Issued December 14, 2004
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
- 6003
- Date
- December 14, 2004
- Company
- Baxter Healthcare CorporationDeerfield, Illinois, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Coagulation factor viii
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RECOMBINATE | 02015137 | Cancelled Post Market |
| RECOMBINATE | 02015145 | Cancelled Post Market |
| RECOMBINATE | 02015129 | Cancelled Post Market |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT per VIAL