Approval · Notice of Compliance 19331 · 2017
PRIMOVIST: Notice of Compliance 19331
Issued May 18, 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
- 19331
- Date
- May 18, 2017
- Company
- Bayer Inc.Elkhart, Indiana, United States
- 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 for primovist in response to health canada's class labelling request issued february 15, 02017 for all gandolinium based contrast agents (gbcas) products with respect to gadolinium (gd) accumulation in brain
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRIMOVIST | Not yet assigned | — |
Medicinal ingredients
- GADOXETATE DISODIUM 181.43 MG per MG