Approval · Notice of Compliance 13869 · 2012
INTELENCE: Notice of Compliance 13869
Issued November 20, 2012
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
- 13869
- Date
- November 20, 2012
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New 25 mg tablet; New indication for pediatric patients 6 to <18 years of age
- Therapeutic class
- Human immunodeficiency virus (hiv) non-nucleoside reverse transcriptase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INTELENCE | 02396750 | Cancelled Post Market |
| INTELENCE | Not yet assigned | — |
Medicinal ingredients
- ETRAVIRINE 25 MG per TAB
- ETRAVIRINE 100 MG per TAB
- ETRAVIRINE 200 MG per TAB