Approval · Notice of Compliance 22596 · 2019
LEMTRADA: Notice of Compliance 22596
Issued September 3, 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
- 22596
- Date
- September 3, 2019
- Company
- Sanofi Genzyme, A Division Of Sanofi-Aventis Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indication: lemtrada (alemtuzumab) is indicated for the management of adult patients with relapsing remitting multiple sclerosis (rrms) with highly active disease defined by clinical and imaging features, despite an adequate course of treatment with at least two other disease modifying treatments (dmts) or where any other dmt is contraindicated or otherwise unsuitable
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEMTRADA | Not yet assigned | — |
Medicinal ingredients
- ALEMTUZUMAB 12 MG per UNIT