Approval · Notice of Compliance 16005 · 2014
DUTASTERIDE: Notice of Compliance 16005
Issued August 27, 2014
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
- 16005
- Date
- August 27, 2014
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Therapeutic class
- Type i and ii 5 alpha-reductase inhibitor
- Canadian reference product
- AVODART (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DUTASTERIDE | 02429012 | Marketed |
Medicinal ingredients
- DUTASTERIDE 0.5 MG per CAP