Approval · Notice of Compliance 18770 · 2016
REVLIMID: Notice of Compliance 18770
Issued December 14, 2016
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
- 18770
- Date
- December 14, 2016
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion to indication: in combination with dexamethasone is indicated for the treatment of multiple myelomw patients who are not eligible for stem cell trasplant. new strength 2.5 mg
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVLIMID | 02459418 | Marketed |
| REVLIMID | Not yet assigned | — |
Medicinal ingredients
- LENALIDOMIDE 2.5 MG per CAP
- LENALIDOMIDE 5 MG per CAP
- LENALIDOMIDE 10 MG per CAP
- LENALIDOMIDE 15 MG per CAP
- LENALIDOMIDE 20 MG per CAP
- LENALIDOMIDE 25 MG per CAP