Approval · Notice of Compliance 9811 · 2008
REVLIMID: Notice of Compliance 9811
Issued October 3, 2008
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
- 9811
- Date
- October 3, 2008
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strengths: 15 mg and 25 mg. new indication: in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one prior therapy.
- Therapeutic class
- Antineoplastic agent / immunomodulatory agent
Products in this notice
Medicinal ingredients
- LENALIDOMIDE 5 MG per CAP
- LENALIDOMIDE 10 MG per CAP
- LENALIDOMIDE 15 MG per CAP
- LENALIDOMIDE 25 MG per CAP