Approval · Notice of Compliance 29661 · 2022
PROGRAF: Notice of Compliance 29661
Issued December 2, 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
- 29661
- Date
- December 2, 2022
- Company
- Astellas Pharma Canada IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph (PM) with a post-market adverse reaction of thrombotic microangiopathy and with the risk of nephrotoxicity. The PM was also reformatted to the Master Template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROGRAF | Not yet assigned | — |
Medicinal ingredients
- TACROLIMUS 0.5 MG per CAP
- TACROLIMUS 1 MG per CAP
- TACROLIMUS 5 MG per CAP
- TACROLIMUS 5 MG per ML