Approval · Notice of Compliance 38169 · 2026
KOVALTRY: Notice of Compliance 38169
Issued August 25, 2026
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
- 38169
- Date
- August 25, 2026
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the drug substance manufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KOVALTRY | 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) 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3,000 UNIT per VIAL