Approval · Notice of Compliance 4120 · 1997
PROGRAF: Notice of Compliance 4120
Issued September 16, 1997
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
- 4120
- Date
- September 16, 1997
- Company
- Fujisawa Canada Inc.Markham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: prophylaxis of kidney rejection and for the treatment of refractory rejection in patients receiving an allogenic kidney
- Therapeutic class
- Immunosuppressant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROGRAF | Not yet assigned | — |
Medicinal ingredients
- TACROLIMUS 5 MG per AMP
- TACROLIMUS 1 MG per CAP
- TACROLIMUS 5 MG per CAP