Approval · Notice of Compliance 31515 · 2023
FOQUEST: Notice of Compliance 31515
Issued August 29, 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
- 31515
- Date
- August 29, 2023
- Company
- Elvium Life SciencesToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To revise the Product Monograph (PM) with the addition of the Preferred Term gynecomastia in section 8.5 Post-Market Adverse Reactions, and remove the word ¿other¿ in relation to ¿other methylphenidate products¿.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOQUEST | Not yet assigned | — |
Medicinal ingredients
- METHYLPHENIDATE HYDROCHLORIDE 25 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 35 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 45 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 55 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 70 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 85 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 100 MG per CAP