Approval · Notice of Compliance 28635 · 2022
ORENCIA: Notice of Compliance 28635
Issued July 21, 2022
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
- 28635
- Date
- July 21, 2022
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Prophylaxis for Acute Graft versus Host Disease: ORENCIA is indicated for the prophylaxis of moderate to severe acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 6 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ORENCIA | Not yet assigned | — |