Approval · Notice of Compliance 19465 · 2017
OMNISCAN: Notice of Compliance 19465
Issued June 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
- 19465
- Date
- June 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 monograph (pm) for omniscan in response to health canada's class-labelling request issued on march 31, 2017 for all gaddolinium-based contrast agents (gbcas) product with respect to gadolinium (gd) accumulation in brain
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OMNISCAN | Not yet assigned | — |
Medicinal ingredients
- GADODIAMIDE 287 MG per ML