Approval · Notice of Compliance 26399 · 2021
BLEXTEN: Notice of Compliance 26399
Issued August 11, 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
- 26399
- Date
- August 11, 2021
- Company
- Aralez Pharmaceuticals Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expand pediatric indication, addition of new dosage forms and to update the Product Monograph to the 2020 format.