Approval · Notice of Compliance 17193 · 2015
DAKLINZA: Notice of Compliance 17193
Issued August 13, 2015
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 17193
- Date
- August 13, 2015
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antiviral agent
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- DACLATASVIR 30 MG per TAB
- DACLATASVIR 60 MG per TAB