Page contentsPage contents Key facts Decision Key facts Active substance zoliflodacin Therapeutic area Infections and infestations Decision number P/0381/2022 PIP number EMA/PE/0000182808 Pharmaceutical form(s) Granules for oral suspension Condition(s) / indication(s) Treatment of gonococcal infection Route(s) of administration Oral use Contact for public enquiries Entasis Therapeutic Inc. E-mail: Enquiries@entasistx.comTel.: +1 7818108940 Decision type PM: decision on the application for modification of an agreed PIP Decision date 06/12/2024 Compliance check done No Decision EMA/PE/0000182808 : EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for zoliflodacinAdopted English (EN) (206.85 KB - PDF)First published: 09/12/2025 View Share this page