HYLORIS PHARMACEUTIC

HYL
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Hyloris Pharmaceuticals SA Receives Complete Response Letter from the US Food and Drug Administration on its Application for the US Registration of Maxigesic IV

07/01/2022 | 03:55am
Hyloris Pharmaceuticals SA announces that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its application for the US registration of Maxigesic IV. The FDA has only requested additional data on one remaining topic. Maxigesic® IV, is a novel, unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, for the treatment of post-operative pain and is currently licensed in more than 100 countries across the globe. It has also been registered in 39 countries and launched in 7 countries including Australia, Germany and Korea. The medicine is protected by several granted patents and pending patent applications.
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