Approval · Notice of Compliance 24814 · 2020
MOVIPREP: Notice of Compliance 24814
Issued December 17, 2020
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
- 24814
- Date
- December 17, 2020
- Company
- Aralez Pharmaceuticals Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph (pm) with safety information related to rare reports of serious cardiac arrhythmias, in response to the health canada advisement letter dated april 27 2020
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MOVIPREP | Not yet assigned | — |
Medicinal ingredients
- ASCORBIC ACID 4.7 G per PCK
- POLYETHYLENE GLYCOL 3350 100 G per PCK
- POTASSIUM CHLORIDE 1.015 G per PCK
- SODIUM ASCORBATE 5.9 G per PCK
- SODIUM CHLORIDE 2.691 G per PCK
- SODIUM SULFATE ANHYDROUS 7.5 G per PCK