Approval · Notice of Compliance 6398 · 2005
TOPAMAX: Notice of Compliance 6398
Issued April 7, 2005
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
- 6398
- Date
- April 7, 2005
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication as monotherapy for the management of patients (adults and children six years and older) with newly diagnosed epilepsy
- Therapeutic class
- Anti-epileptic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TOPAMAX | Not yet assigned | — |
Medicinal ingredients
- TOPIRAMATE 15 MG per CAP
- TOPIRAMATE 25 MG per CAP
- TOPIRAMATE 50 MG per CAP
- TOPIRAMATE 25 MG per TAB
- TOPIRAMATE 50 MG per TAB
- TOPIRAMATE 100 MG per TAB
- TOPIRAMATE 200 MG per TAB
- TOPIRAMATE 300 MG per TAB
- TOPIRAMATE 400 MG per TAB