Approval · Notice of Compliance 33609 · 2024
TAGRISSO: Notice of Compliance 33609
Issued July 10, 2024
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
- 33609
- Date
- July 10, 2024
- 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: [TAGRISSO in combination with pemetrexed and platinum-based chemotherapy for the first line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations/
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