Preparation for the Chinese application for prulifloxacin
First written in FY2017-Q1. 10 of 13 entries say "Restated". Latest entry: FY2021-Q1.
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- FY2021-Q1AchievedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) filed the regulatory application in China in 2017, and approval was obtained in June 2020.」
The program advanced from preparation for and filing of the regulatory application in China, and approval was obtained in June 2020. - FY2020-Q3RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The status of the completed Phase 3 trial in China and the licensee's regulatory application filed in September 2017 is being reiterated. - FY2020-Q2RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The status of the completed Phase 3 trial in China and the regulatory application filed in September 2017 is being reiterated. - FY2020-Q1RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The status of the completed Phase 3 trial in China and the regulatory application filed in September 2017 is being reiterated. - FY2019-Q3RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The status of the completed Phase 3 trial in China and the regulatory application filed in September 2017 is being reiterated. - FY2019-Q2RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September of the previous year.」
The status of the completed Phase 3 trial in China and the licensee's regulatory application filed in September of the previous year is being reiterated. - FY2019-Q1RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September of the previous year.」
The status of the completed Phase 3 trial in China and the regulatory application filed in September of the previous year is being reiterated. - FY2018-Q3RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The status of the completed Phase 3 trial in China and the regulatory application filed in September 2017 is being reiterated. - FY2018-Q2AdvancedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) completed the Phase 3 trial in China and filed the regulatory application in September 2017.」
The program advanced from the stage in which the Phase 3 trial in China had been completed and the licensee was preparing the application to the regulatory application stage in September 2017. - FY2018-Q1RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) has completed the Phase 3 trial in China and is currently preparing the application.」
The status of the completed Phase 3 trial in China and the licensee's preparation of the application is being reiterated. - FY2017-Q3RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) has completed the Phase 3 trial in China and is currently preparing the application.」
Following completion of the Phase 3 trial in China, the status of the licensee preparing the application is being reiterated. - FY2017-Q2RestatedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) has completed the Phase 3 trial in China and is currently preparing the application.」
The status of the completed Phase 3 trial in China and the licensee's preparation of the application is being reiterated. - FY2017-Q1First statedAnnual report
「For prulifloxacin, a synthetic antibacterial agent, the licensee Rees Pharma (Hong Kong) has completed the Phase 3 trial in China and is currently preparing the application.」
The Phase 3 trial in China has been completed, and the licensee has advanced to the preparation stage for the regulatory application.