Approval · Notice of Compliance 32053 · 2023
RESOTRAN: Notice of Compliance 32053
Issued November 9, 2023
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
- 32053
- Date
- November 9, 2023
- Company
- Amdipharm LimitedNorthwood, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- To update the Product Monograph (PM) to align with the Master template. Administrative: Change in Product Ownership
Products in this notice
Medicinal ingredients
- PRUCALOPRIDE SUCCINATE 1 MG per TAB
- PRUCALOPRIDE SUCCINATE 2 MG per TAB