Approval · Notice of Compliance 20784 · 2018
DOTAREM: Notice of Compliance 20784
Issued April 24, 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
- 20784
- Date
- April 24, 2018
- Company
- GuerbetRoissy Cdg Cedex, Val-D'Oise, France
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To expand the indcation of contrast enhancement during cranial and spinal mri investigations to children younger than 2 years of age
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | Not yet assigned | — |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML