Approval · Notice of Compliance 34262 · 2024
CALQUENCE: Notice of Compliance 34262
Issued October 22, 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
- 34262
- Date
- October 22, 2024
- 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. Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Addition of a manufacturing site and/or manufacturer involving testing [e.g. release,stability. Change in the manufacturing process for the intermediate
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CALQUENCE | Not yet assigned | — |
Medicinal ingredients
- ACALABRUTINIB MALEATE 100 MG per TAB