Approval · Notice of Compliance 925 · 2003
IRESSA: Notice of Compliance 925
Issued December 17, 2003
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
- 925
- Date
- December 17, 2003
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Epidermal growth factor receptor (egfr) tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IRESSA | 02248676 | Marketed |
Medicinal ingredients
- GEFITINIB 250 MG per TAB