Approval · Notice of Compliance 22302 · 2019
IDELVION: Notice of Compliance 22302
Issued June 18, 2019
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
- 22302
- Date
- June 18, 2019
- Company
- Csl Behring Canada IncOttawa, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IDELVION | Not yet assigned | — |
| IDELVION | 02489627 | Approved |
Medicinal ingredients
- COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 250 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 500 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 1,000 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 2,000 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 3,500 UNIT per VIAL