Approval · Notice of Compliance 26650 · 2021
HYRIMOZ: Notice of Compliance 26650
Issued September 10, 2021
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
- 26650
- Date
- September 10, 2021
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of the indications : Pediatric Crohn¿s Disease reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ¿ 40 kg with severely active Crohn¿s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist. Hidradenitis Suppurativa treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ¿ 30 kg) who have not responded to conventional therapy (including systemic antibiotics). Pediatric Uveitis treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYRIMOZ | Not yet assigned | — |
Medicinal ingredients
- ADALIMUMAB 20 MG per SYR
- ADALIMUMAB 40 MG per SYR
- ADALIMUMAB 40 MG per PEN