Approval · Notice of Compliance 26042 · 2021
RAVICTI: Notice of Compliance 26042
Issued June 10, 2021
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
- 26042
- Date
- June 10, 2021
- Company
- Horizon Therapeutics Ireland DacDun Laoghaire Co. Dublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional API and product manufacturing sites and a shelf life extension.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RAVICTI | Not yet assigned | — |
Medicinal ingredients
- GLYCEROL PHENYLBUTYRATE 1.1 G per ML