Approval · Notice of Compliance 14446 · 2013
REVLIMID: Notice of Compliance 14446
Issued June 6, 2013
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
- 14446
- Date
- June 6, 2013
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of conditions as per the letter of Unertaking dated January 15, 2008 indicated for the treatment of patients with transfusion-dependent anemia due to low or intermediate 1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
- Therapeutic class
- Antineoplastic agent, immunomodulating agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVLIMID | Not yet assigned | — |
Medicinal ingredients
- LENALIDOMIDE 5 MG per CAP
- LENALIDOMIDE 10 MG per CAP
- LENALIDOMIDE 15 MG per CAP
- LENALIDOMIDE 25 MG per CAP