Approval · Notice of Compliance 19408 · 2017
PROCYSBI: Notice of Compliance 19408
Issued June 13, 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
- 19408
- Date
- June 13, 2017
- Company
- Horizon Pharma Ireland Ltd
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
Products in this notice
Medicinal ingredients
- CYSTEAMINE BITARTRATE 25 MG per CAP
- CYSTEAMINE BITARTRATE 75 MG per CAP