Page contentsPage contents Key facts Decision Key facts Active substance Furosemide Therapeutic area Cardiovascular diseases Decision number P/0315/2023 PIP number EMEA-003316-PIP01-22 Pharmaceutical form(s) Age appropriate oral dosage formulation Condition(s) / indication(s) Treatment of fluid retention Route(s) of administration Oral use Contact for public enquiries Proveca Pharma Limited Tel. +353 15136233E-mail: info@proveca.com Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 09/08/2023 Compliance check done No Decision P/0315/2023 : EMA decision of 9 August 2023 on the agreement of a paediatric investigation plan for furosemide (EMEA-003316-PIP01-22)Reference Number: EMA/336065/2023 English (EN) (234.46 KB - PDF)First published: 13/09/2024 View Share this page