Hyloris announces approval of Maxigesic IV in eight European countries (GlobeNewswire) - Sep 7, 2020 - "Hyloris Pharmaceuticals SA...today announces the approval of Maxigesic® IV in eight European countries....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....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....The NDA filing of Maxigesic® IV in the US is expected to occur by the end of 2020."
European regulatory • Launch Europe • NDA • CNS Disorders • Pain
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