Peramivir hydrate was approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on January 13, 2010, and approved by the U.S. Food and Drug Administration (FDA) on December 19, 2014. It was co-developed and co-marketed as Rapiacta® by BioCryst and Shionogi in Japan.
Peramivir hydrate is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and thereby preventing new viruses from emerging from infected cells. It is indicated for the treatment of influenza A and B viral infections.
Rapiacta® is available as injection solution for intravenous, containing 150 mg/300 mg Peramivir hydrate. The recommended dose is once a day by an intravenous drip infusion over a period of 15 minutes or longer.
Update Date:2016-05-17
Update Date:2015-07-29
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2014-12-19 | Marketing approval | Rapivab | Influenza infection | Solution | 200 mg/20 ml | BioCryst | Standard |
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2010-01-13 | Marketing approval | Rapiacta | Influenza infection | Injection, Solution | Eq. 150 mg/300 mg Peramivir | BioCryst, Shionogi |
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2013-04-05 | Marketing approval | 力纬 | Influenza infection | Injection, Solution | 100ml | 广州南新制药 | 1.1 |
Update Date:2015-08-27
Update Date:2015-08-31
Update Date:2015-10-09