Approval · Notice of Compliance 14414 · 2013
SOLIRIS: Notice of Compliance 14414
Issued May 31, 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
- 14414
- Date
- May 31, 2013
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Administrative - manufacturer name change
- Therapeutic class
- Complement inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOLIRIS | 02322285 | Marketed |
Medicinal ingredients
- ECULIZUMAB 10 MG per ML