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This orodispersible, mango-flavoured tablet has already demonstrated safety and efficacy against soil-transmitted helminths in a 2022/2023 phase II/III pivotal trial. The results are already accepted for publication in Lancet Infectious Diseases and have been submitted to regulators. The FDC is being evaluated by the European Medicines Agency (EMA) under the EU-M4All procedure, and Ghana's FDA, with decisions anticipated in early 2025, which will be followed by WHO consideration for prequalification.
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This orodispersible, mango-flavoured tablet has already demonstrated safety and efficacy against soil-transmitted helminths in a 2022/2023 phase II/III pivotal trial. The results of this trial are already accepted for publication in Lancet Infectious Diseases and have been submitted to regulators. The FDC is being evaluated by the European Medicines Agency (EMA) under the EU-M4All procedure, and Ghana's FDA, with decisions anticipated in early 2025, which will be followed by WHO consideration for prequalification.
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