Approval · Notice of Compliance 19702 · 2017
OMNIPAQUE: Notice of Compliance 19702
Issued August 23, 2017
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
- 19702
- Date
- August 23, 2017
- Company
- Ge Healthcare Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To improve the safety information in the product mnograph for omnipaque in response to health canada's class labelling change request for all iodine-based contrast media with respect to thyroid dysfunction