Approval · Notice of Compliance 14183 · 2013
SOLIRIS: Notice of Compliance 14183
Issued March 1, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 14183
- Date
- March 1, 2013
- Company
- Alexion Pharmaceuticals Inc
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication for the treatment of patients with atypical hemolytic uremic syndrome to reduce complement-mediated thrombotic microangiopathy
- Therapeutic class
- Complement inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOLIRIS | Not yet assigned | — |
Medicinal ingredients
- ECULIZUMAB 300 MG per VIAL