Approval · Notice of Compliance 18445 · 2016
RAVICTI: Notice of Compliance 18445
Issued August 26, 2016
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
- 18445
- Date
- August 26, 2016
- Company
- Horizon Pharma Ireland Ltd
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To propose revisions to the inner and outer labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RAVICTI | Not yet assigned | — |
Medicinal ingredients
- GLYCEROL PHENYLBUTYRATE 1.1 G per ML