Approval · Notice of Compliance 22336 · 2019
ZESTORETIC: Notice of Compliance 22336
Issued June 28, 2019
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
- 22336
- Date
- June 28, 2019
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To update the Product Monograph with information about the new adverse event non-melanoma skin cancer observed during and after use of hydrochlorothiazide, in response to an Advisement Letter issued by Health Canada.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZESTORETIC | Not yet assigned | — |
Medicinal ingredients
- HYDROCHLOROTHIAZIDE 12.5 MG per TAB
- LISINOPRIL 10 MG per TAB
- LISINOPRIL 20 MG per TAB
- HYDROCHLOROTHIAZIDE 25 MG per TAB