Approval · Notice of Compliance 21977 · 2019
APO-MYCOPHENOLATE: Notice of Compliance 21977
Issued March 15, 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
- 21977
- Date
- March 15, 2019
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Licensing agreement between two companies. revisions to the labelling
- Canadian reference product
- CELLCEPT (Hoffmann-La Roche Limited)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-MYCOPHENOLATE | 02352559 | Dormant |
Medicinal ingredients
- MYCOPHENOLATE MOFETIL 250 MG per CAP