20 November 2019 - The Specialty Pharma Company Paoin today announces that a marketing authorisation application for remimazolam, Paion’s ultra-short-acting intravenous benzodiazepine sedative/anesthetic, for procedural sedation has been submitted to the EMA.

The application includes the data from a comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy. In a pre-submission meeting with the EMA held earlier this year, the agency indicated that these data would be sufficient for submitting an application in procedural sedation. The review process typically takes about one year.

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