Approval · Notice of Compliance 11716 · 2010
REVATIO: Notice of Compliance 11716
Issued September 16, 2010
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
- 11716
- Date
- September 16, 2010
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to indication for tablets: delay in clinical worsening for PAH patients already stabilised on epoprostenol therapy
- Therapeutic class
- cGMP-specific phosphodiesterase 5 inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVATIO | Not yet assigned | — |
Medicinal ingredients
- SILDENAFIL CITRATE 20 MG per TAB