Approval · Notice of Compliance 35244 · 2025
TAGRISSO: Notice of Compliance 35244
Issued April 23, 2025
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
- 35244
- Date
- April 23, 2025
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Addition of new indication: treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TAGRISSO | Not yet assigned | — |
Medicinal ingredients
- OSIMERTINIB MESYLATE 40 MG per TAB
- OSIMERTINIB MESYLATE 80 MG per TAB