Approval · Notice of Compliance 29188 · 2022
ACTEMRA: Notice of Compliance 29188
Issued October 13, 2022
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
- 29188
- Date
- October 13, 2022
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication : ACTEMRA is indicated for the treatment of hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids, and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACTEMRA | Not yet assigned | — |
Medicinal ingredients
- TOCILIZUMAB 80 MG per 4ML
- TOCILIZUMAB 200 MG per 10ML
- TOCILIZUMAB 400 MG per 20ML