Approval · Notice of Compliance 919 · 2001
RECOMBINATE: Notice of Compliance 919
Issued April 27, 2001
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
- 919
- Date
- April 27, 2001
- Company
- Baxter Healthcare Corporation, Hyland ImmunoGlendale, California, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New drug substance manufacturing suite
- Therapeutic class
- Antihemophilic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RECOMBINATE | 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