Approval · Notice of Compliance 13083 · 2012
IRESSA: Notice of Compliance 13083
Issued March 7, 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
- 13083
- Date
- March 7, 2012
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Clinical Trials and Overdosage sections of the Product Monograph
- Therapeutic class
- Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IRESSA | Not yet assigned | — |
Medicinal ingredients
- GEFITINIB 250 MG per TAB