Approval · Notice of Compliance 14780 · 2013
ISENTRESS: Notice of Compliance 14780
Issued October 4, 2013
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
- 14780
- Date
- October 4, 2013
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Long term (240 weeks) safety and efficacy data
- Therapeutic class
- Human immunodeficiency virus integrase strand transfer inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ISENTRESS | Not yet assigned | — |
Medicinal ingredients
- RALTEGRAVIR POTASSIUM 400 MG per TAB
- RALTEGRAVIR POTASSIUM 25 MG per TAB
- RALTEGRAVIR POTASSIUM 100 MG per TAB