Approval · Notice of Compliance 35185 · 2025
ACT METHYLPHENIDATE ER: Notice of Compliance 35185
Issued April 14, 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
- 35185
- Date
- April 14, 2025
- Company
- Teva Canada LimitedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph
- Canadian reference product
- CONCERTA (Janssen Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACT METHYLPHENIDATE ER | Not yet assigned | — |
Medicinal ingredients
- METHYLPHENIDATE HYDROCHLORIDE 18 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 27 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 36 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 54 MG per TAB