Approval · Notice of Compliance 14899 · 2013
INCIVEK: Notice of Compliance 14899
Issued October 22, 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
- 14899
- Date
- October 22, 2013
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of shelf life for telaprevir spray-dried suspension (sdd) from 24 to 48 months
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INCIVEK | Not yet assigned | — |
Medicinal ingredients
- TELAPREVIR 375 MG per TAB