Approval · Notice of Compliance 18326 · 2016
MEPRON: Notice of Compliance 18326
Issued July 28, 2016
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
- 18326
- Date
- July 28, 2016
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- This supplemental new drug submission was filed to seek approval of 1500 mg once daily dosing in patients who have difficulty swallowing
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MEPRON | Not yet assigned | — |
Medicinal ingredients
- ATOVAQUONE 750 MG per 5ML