PAION AG (FRA:PA8) EQS-Adhoc: PAION receives European Commission approval of remimazolam for the Induction and maintenance of general anesthesia in adults
Transparency directive : regulatory news
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EQS-Ad-hoc: PAION AG / Key word(s): Regulatory Approval PAION receives European Commission approval of remimazolam for the Induction and maintenance of general anesthesia in adults Aachen (Germany), 03 April 2023 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces that today the European Commission (EC) has approved remimazolam for the induction and maintenance of general anesthesia in adults in the EU (including the countries of the European Economic Area, EEA). In addition, the UK Medicines & Healthcare products Regulatory Agency (MHRA) is currently reviewing a possible approval in the UK.
End of inside information Information and Explanation of the Issuer to this announcement: The approval is based on the data from a comprehensive clinical program in general anesthesia. This demonstrated, among other things, a lower incidence of hemodynamic side effects compared with propofol. Remimazolam was already approved in Japan and South Korea for general anesthesia. Gregor Siebert, CEO at PAION AG, commented: “We are excited that the European Commission has approved remimazolam, and thank all healthcare professionals, patients and partners who have been involved in the development of remimazolam. After having successfully started the marketing of remimazolam for the indication procedural sedation in the European core markets, we continue to drive forward the sales activities here and are planning the market launch in general anesthesia in the second half of 2023. Together with our further products angiotensin II and eravacycline, we are thus offering an attractive portfolio for both anesthetists and intensive care specialists in important markets around the world.”
Contact Ralf Penner Senior Vice President Investor Relations & Corporate Communications PAION AG Heussstrasse 25 52078 Aachen – Germany Phone +49 241 4453-152 E-mail r.penner@paion.com www.paion.com
Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION AG's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
03-Apr-2023 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English |
| Company: | PAION AG |
| Heussstraße 25 | |
| 52078 Aachen | |
| Germany | |
| Phone: | +49 (0)241-4453-0 |
| Fax: | +49 (0)241-4453-100 |
| E-mail: | info@paion.com |
| Internet: | www.paion.com |
| ISIN: | DE000A0B65S3 |
| WKN: | A0B65S |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 1593337 |
| End of Announcement | EQS News Service |
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1593337 03-Apr-2023 CET/CEST