Approval · Notice of Compliance 36087 · 2025
TAGRISSO: Notice of Compliance 36087
Issued October 1, 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.
- Notice number
- 36087
- Date
- October 1, 2025
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the starting material. Change in the manufacturing process for the intermediate
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