Approval · Notice of Compliance 36097 · 2025
BLEXTEN: Notice of Compliance 36097
Issued October 1, 2025
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
- 36097
- Date
- October 1, 2025
- 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
- Addition of new indication: the treatment of ocular signs and symptoms of seasonal and perennial allergic conjunctivitis in adults. Addition of new route of administration: Ophthalmic. Addition of new dosage form: Ophthalmic solution. New package labels. New package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BLEXTEN | 02561514 | Approved |
Medicinal ingredients
- BILASTINE 6 MG per ML