Approval · Notice of Compliance 25944 · 2020
SONOVUE: Notice of Compliance 25944
Issued August 20, 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
- 25944
- Date
- August 20, 2020
- Company
- Bracco Imaging CanadaVille D'Anjou, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- An additional indication for use in ultrasonography of the excretory urinary tract in paediatric patients with known or suspected vesicoureteral reflux (VUR)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SONOVUE | 02287684 | Marketed |
Medicinal ingredients
- SULFUR HEXAFLUORIDE 8 MCL per ML