Approval · Notice of Compliance 34636 · 2025
BACLOFEN INJECTION: Notice of Compliance 34636
Issued January 7, 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
- 34636
- Date
- January 7, 2025
- Company
- Hikma Canada LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Update to Product Monograph (to align with CRP approved PM). Update to package insert.
- Canadian reference product
- LIORESAL INTRATHECAL (Novartis Pharmaceuticals Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BACLOFEN INJECTION | Not yet assigned | — |