Approval · Notice of Compliance 22319 · 2019
CELLCEPT: Notice of Compliance 22319
Issued June 26, 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
- 22319
- Date
- June 26, 2019
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Updates to inner and outer labels for CELLCEPT I.V. and package insert for both CELLCEPT and CELLCEPT I.V. to be in compliance with Plain Language Labelling requirements
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CELLCEPT | Not yet assigned | — |
| CELLCEPT I.V. | Not yet assigned | — |
Medicinal ingredients
- MYCOPHENOLATE MOFETIL 500 MG per TAB
- MYCOPHENOLATE MOFETIL 250 MG per TAB
- MYCOPHENOLATE MOFETIL 200 MG per ML
- MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500 MG per VIAL