Hyloris Pharmaceuticals SA announced approval of Maxigesic® IV in eight European countries. Maxigesic® IV is Hyloris’ second product to reach the market, after Sotalol IV. Maxigesic® IV is the result of a co-development partnership with AFT Pharmaceuticals of New Zealand, who will launch the product through several distribution and licensing partners. Through a series of decentralized procedures, which allows a product to be approved in more than one EU member state in parallel, the product is now being rolled out over Europe. The decentralized procedures which in total included 18 countries was concluded positively on the 29th April 2020 and was followed by national license applications. To date, AFT has obtained national Marketing Authorizations in Belgium, Sweden, Hungary, Romania, Croatia, Lithuania, Slovakia and Malta, while the remaining Marketing Authorizations are expected in the upcoming period. The commercialization in these territories is expected to start in early 2021. Additional procedures have been initiated to obtain approval in further countries within the EU. In July 2020, AFT completed the enrolment of the open-label, multiple-dose, single arm exposure clinical Phase III trial of Maxigesic® IV in 232 patients with acute pain following orthopedic, general or plastic surgery. The NDA filing of Maxigesic® IV in the US is expected to occur by the end of 2020.