Approval · Notice of Compliance 31816 · 2023
APO-METHYLPHENIDATE: Notice of Compliance 31816
Issued October 10, 2023
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
- 31816
- Date
- October 10, 2023
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph. Update to the Package Insert. Update to labels to align with Plain Language Labelling Regulations
- Canadian reference product
- RITALIN AND RITALIN-SR
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-METHYLPHENIDATE | Not yet assigned | — |
| APO-METHYLPHENIDATE SR | Not yet assigned | — |
Medicinal ingredients
- METHYLPHENIDATE HYDROCHLORIDE 5 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 10 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 20 MG per TAB