Approval · Notice of Compliance 26331 · 2021
CEFTIN: Notice of Compliance 26331
Issued July 27, 2021
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
- 26331
- Date
- July 27, 2021
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the Product Monograph (PM) with i) the removal of the bronchitis, pneumonia, and sinusitis indications; ii) the addition of text on the optimal use of the drug; iii) the removal of text related to the tablet dosage forms; iv) improving the clarity of the reconstitution and storage instructions; v) to update to the 2020 PM format.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CEFTIN | Not yet assigned | — |
Medicinal ingredients
- CEFUROXIME AXETIL 125 MG per 5ML