Approval · Notice of Compliance 36206 · 2025
JIVI: Notice of Compliance 36206
Issued October 20, 2025
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
- 36206
- Date
- October 20, 2025
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Indication expansion: JIVI (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) is indicated in previously treated adults, adolescents and children (7 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes • Control and prevention of episodic bleeding • Peri-operative management of bleeding (surgical prophylaxis)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JIVI | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 3,000 UNIT per VIAL