Approval · Notice of Compliance 9487 · 2008
CONCERTA: Notice of Compliance 9487
Issued April 15, 2008
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
- 9487
- Date
- April 15, 2008
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: treatment of attention deficit hyperactivity disorder (adhd) in adults (>18 years of age).
- Therapeutic class
- Cns stimulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CONCERTA | 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