Approval · Notice of Compliance 23944 · 2020
SINGULAIR: Notice of Compliance 23944
Issued July 23, 2020
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
- 23944
- Date
- July 23, 2020
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update Product Monograph to include changes related to pregnancy language and changes to the Serious Adverse Events table in Part III. & Addition of the Serious Warnings and Precautions Box for neuropsychiatric events.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SINGULAIR | Not yet assigned | — |
Medicinal ingredients
- MONTELUKAST SODIUM 10.4 MG per TAB
- MONTELUKAST SODIUM 5.2 MG per TAB
- MONTELUKAST SODIUM 4.16 MG per TAB
- MONTELUKAST SODIUM 4.16 MG per PCK