Approval · Notice of Compliance 16161 · 2014
COMPLERA: Notice of Compliance 16161
Issued October 3, 2014
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
- 16161
- Date
- October 3, 2014
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- The PM was updated in the following sections: Indications & Clinical Use, Contraindications, Warnings & Precautions, Adverse Reactions, Drug Interactions, Dosage & Administration, Virology and Consumer Information.
- Therapeutic class
- Antiretroviral Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COMPLERA | 02374129 | Marketed |
Medicinal ingredients
- EMTRICITABINE 200 MG per TAB
- TENOFOVIR DISOPROXIL FUMARATE 300 MG per TAB
- RILPIVIRINE HYDROCHLORIDE 25 MG per TAB