Approval · Notice of Compliance 10257 · 2009
EXJADE: Notice of Compliance 10257
Issued June 17, 2009
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
- 10257
- Date
- June 17, 2009
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the Adverse Reactions, Dosage and Administration (maintenance dose) and Clinical Trials section
- Therapeutic class
- Iron chelating agent
- With conditions
- Yes (NOC/c)
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