Following discussions with the EMA, Paion has added filing for procedural sedation (PS) in Europe to the list of potential near-term filings for remimazolam. Mundipharma filed for approval in general anaesthesia (GA) in Japan in December 2018, while Cosmo is expected to file for PS in the US shortly. Paion’s GA Phase III in Europe is on track to complete recruitment by the end of 2019. The filings will be an important step towards commercialising remimazolam and establishing Paion as a
01 Apr 2019
Paion - Near-term EU sedation filing added to the list
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Paion - Near-term EU sedation filing added to the list
Following discussions with the EMA, Paion has added filing for procedural sedation (PS) in Europe to the list of potential near-term filings for remimazolam. Mundipharma filed for approval in general anaesthesia (GA) in Japan in December 2018, while Cosmo is expected to file for PS in the US shortly. Paion’s GA Phase III in Europe is on track to complete recruitment by the end of 2019. The filings will be an important step towards commercialising remimazolam and establishing Paion as a