Approval · Notice of Compliance 10745 · 2009
ADVATE: Notice of Compliance 10745
Issued November 4, 2009
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
- 10745
- Date
- November 4, 2009
- Company
- Baxter Healthcare CorporationDeerfield, Illinois, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional dose strength of 3000 IU/vial for final drug product and increase the upper limit of the Factor VIII potency specification from 2400 IU/vial to 3600 IU/vial
- Therapeutic class
- Coagulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVATE | Not yet assigned | — |
| ADVATE | 02337193 | Dormant |
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