Approval · Notice of Compliance 27561 · 2022
BETAHISTINE: Notice of Compliance 27561
Issued February 10, 2022
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
- 27561
- Date
- February 10, 2022
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Administrative: Licensing Agreement Between Two Companies
- Canadian reference product
- SERC (Solvay Pharma Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BETAHISTINE | 02525011 | Approved |
| BETAHISTINE | 02466449 | Dormant |
| BETAHISTINE | 02466457 | Dormant |
Medicinal ingredients
- BETAHISTINE HYDROCHLORIDE 8 MG per TAB
- BETAHISTINE HYDROCHLORIDE 16 MG per TAB
- BETAHISTINE HYDROCHLORIDE 24 MG per TAB