EMEA-003277-PIP02-23 - paediatric investigation plan

EMEA-003277-PIP02-23 - paediatric investigation plan live attenuated respiratory syncytial virus (RSV) PIP Human Key facts Active substance live attenuated respiratory syncytial virus (RSV) Therapeutic area Infections and infestations Decision number P/0153/2024 PIP number EMEA-003277-PIP02-23 Pharmaceutical form(s) Nasal spray (solution) Condition(s) / indication(s) Prevention of respiratory syncytial virus disease Route(s) of administration Nasal use Contact for public enquiries Sanofi Winthrop Industrie E-mail: contact-us@sanofi.com Tel: +33 1 69 74 56 95 Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 06/05/2024 Compliance check done No Decision P/0153/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for live attenuated respiratory syncytial virus (RSV) (EMEA-003277-PIP02-23) Adopted Reference Number: EMA/148126/2024 English (EN) (239.53 KB - PDF) First published: 10/06/2025 View Related content Live attenuated respiratory syncytial virus (RSV) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision English (EN) (84.41 KB - PDF) First published: 25/03/2026 View Share this page