Approval · Notice of Compliance 34095 · 2024
DOMPERIDONE: Notice of Compliance 34095
Issued September 25, 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
- 34095
- Date
- September 25, 2024
- Company
- Sun Pharma Canada Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Administrative: Change in manufacturer name. Update to Product Monograph (to align with CRP approved PM)
- Canadian reference product
- APO-DOMPERIDONE (Apotex Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOMPERIDONE | 02408937 | Approved |
Medicinal ingredients
- DOMPERIDONE MALEATE 10 MG per TAB