Approval · Notice of Compliance 14848 · 2013
VOLIBRIS: Notice of Compliance 14848
Issued October 10, 2013
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
- 14848
- Date
- October 10, 2013
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add a brief description of a long-term, open-label study in part II; detailed pharmacology section of the product monograph
- Therapeutic class
- Endothelin receptor antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VOLIBRIS | Not yet assigned | — |
Medicinal ingredients
- AMBRISENTAN 5 MG per TAB
- AMBRISENTAN 10 MG per TAB