Approval · Notice of Compliance 20595 · 2018
OMNISCAN: Notice of Compliance 20595
Issued March 5, 2018
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
- 20595
- Date
- March 5, 2018
- 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 update the safety information in the product monograph for gadeovist with respect to risk of brain deposition of gadolinium with repeated use of gadolinium-based contrast agents (gbcas)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OMNISCAN | 02172771 | Marketed |
Medicinal ingredients
- GADODIAMIDE 287 MG per ML