Approval · Notice of Compliance 25284 · 2021
REVATIO: Notice of Compliance 25284
Issued February 25, 2021
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
- 25284
- Date
- February 25, 2021
- Company
- Upjohn Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the safety information in the adverse reactions, post market adverse drug reactions, and the action and clinical pharmacology sections for pediatrics with persistent pulmonary hypertension
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVATIO | Not yet assigned | — |
Medicinal ingredients
- SILDENAFIL CITRATE 20 MG per TAB
- SILDENAFIL CITRATE 0.8 MG per ML