Approval · Notice of Compliance 9952 · 2008
IRESSA: Notice of Compliance 9952
Issued December 19, 2008
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
- 9952
- Date
- December 19, 2008
- 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 Product Monograph sections: Clinical Pharmacology; Warnings; Adverse Reactions; Toxicology; and Information for the Patient.
- Therapeutic class
- Epidermal growth factor receptor-tyrosine kinase inhibitor (egfr-tki)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IRESSA | Not yet assigned | — |
Medicinal ingredients
- GEFITINIB 250 MG per TAB