Approval · Notice of Compliance 13587 · 2012
EXJADE: Notice of Compliance 13587
Issued August 24, 2012
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
- 13587
- Date
- August 24, 2012
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: For the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older
- Therapeutic class
- Iron Chelating Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EXJADE | Not yet assigned | — |
Medicinal ingredients
- DEFERASIROX 125 MG per TAB
- DEFERASIROX 250 MG per TAB
- DEFERASIROX 500 MG per TAB