Approval · Notice of Compliance 17040 · 2015
SOLIRIS: Notice of Compliance 17040
Issued June 30, 2015
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
- 17040
- Date
- June 30, 2015
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of condditions as per the revised letter of undertaking dated june 4 2013 for the treatment of atypical hemolytic uremic syndrome in children less than 13 years of age and/or wieighing less than 40 kg
- Therapeutic class
- C5 complement inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOLIRIS | Not yet assigned | — |
Medicinal ingredients
- ECULIZUMAB 300 MG per VIAL