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27/01/2023 12:59
EQS-Adhoc: PAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adultsEQS-Ad-hoc: PAION AG / Key word(s): Miscellaneous PAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults Aachen (Germany), 27 January 2023 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces that today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has published a positive opinion recommending the approval of remimazolam for the induction and maintenance of general anesthesia in adults. The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for remimazolam in the EU (including European Economic Area (EEA) countries) is expected in the first half of 2023. In addition, the UK Medicines & Healthcare products Regulatory Agency (MHRA) will also consider a potential approval in Great Britain. Information and Explanation of the Issuer to this announcement: The positive CHMP opinion for remimazolam is based on the data from a comprehensive clinical program in general anesthesia. Remimazolam was already approved in Japan and South Korea for general anesthesia. Gregor Siebert, CEO at PAION AG, commented: “This positive CHMP opinion for remimazolam brings us closer to our ambition to delivering the first innovative treatment option for anesthesia in Europe for decades. We will drive forward the necessary preparations to make the product available very soon to patients and physicians for general anesthesia with a plan to launch in the second half of 2023.” Contact Ralf Penner 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. 27-Jan-2023 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
1541303 27-Jan-2023 CET/CEST Source : Webdisclosure.com |
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