Approval · Notice of Compliance 3362 · 2003
CELLCEPT: Notice of Compliance 3362
Issued January 8, 2003
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
- 3362
- Date
- January 8, 2003
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: prophylaxis of organ rejection in pediatric patients (2 to 18 years) receiving allogeneic renal transplants in combination with cyclosporine and corticosteroids
- Therapeutic class
- Immunosuppressant agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CELLCEPT | Not yet assigned | — |
Medicinal ingredients
- MYCOPHENOLATE MOFETIL 250 MG per CAP
- MYCOPHENOLATE MOFETIL 500 MG per TAB
- MYCOPHENOLATE MOFETIL 200 MG per ML
- MYCOPHENOLATE MOFETIL 500 MG per VIAL