Approval · Notice of Compliance 30826 · 2023
KIVEXA: Notice of Compliance 30826
Issued May 19, 2023
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
- 30826
- Date
- May 19, 2023
- Company
- Viiv Healthcare UlcMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the Product Monograph (PM) to remove a warning related to the risk of sexual Human Immunodeficiency Virus-1 (HIV-1) transmission; add information that Kivexa tablets contain sunset yellow aluminium lake which may cause allergic-type reaction; update the list of antiretroviral agents that should not be co-administered with Kivexa; and update the PM to the master template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KIVEXA | Not yet assigned | — |
Medicinal ingredients
- LAMIVUDINE 300 MG per TAB
- ABACAVIR SULFATE 600 MG per TAB