Approval · Notice of Compliance 4829 · 2004
TRILEPTAL: Notice of Compliance 4829
Issued August 13, 2004
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
- 4829
- Date
- August 13, 2004
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for use as monotherapy in children with partial seizures and between 6-16 years of age
- Therapeutic class
- Anti-epileptic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRILEPTAL | Not yet assigned | — |
Medicinal ingredients
- OXCARBAZEPINE 150 MG per TAB
- OXCARBAZEPINE 300 MG per TAB
- OXCARBAZEPINE 600 MG per TAB
- OXCARBAZEPINE 60 MG per ML