Approval · Notice of Compliance 18337 · 2016
ENTRESTO: Notice of Compliance 18337
Issued August 4, 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
- 18337
- Date
- August 4, 2016
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To revise the dosage strengths of sacubitril and valsartan in the product monograph, package insert and product labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ENTRESTO | Not yet assigned | — |
Medicinal ingredients
- VALSARTAN 26 MG per TAB
- SACUBITRIL 24 MG per TAB
- VALSARTAN 51 MG per TAB
- SACUBITRIL 49 MG per TAB
- VALSARTAN 103 MG per TAB
- SACUBITRIL 97 MG per TAB