EMEA-003318-PIP01-22 - paediatric investigation plan

EMEA-003318-PIP01-22 - paediatric investigation plan modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains) (qIRV) PIP Human Key facts Active substance modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains) (qIRV) Therapeutic area Vaccines Decision number P/0255/2023 PIP number EMEA-003318-PIP01-22 Pharmaceutical form(s) Concentrate for solution for injection Condition(s) / indication(s) Prevention of influenza Route(s) of administration Intramuscular use Contact for public enquiries Pfizer Europa MA EEIG Email: PIP_Enquiries@pfizer.com Tel. +44 1304646607 Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 14/07/2023 Compliance check done No Decision P/0255/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B strains) Reference Number: EMA/304055/2023 English (EN) (234.66 KB - PDF) First published: 16/07/2024 View Related content modRNA encoding 4 influenza HA antigens (2 for influenza A and 2 for influenza B stains) (qIRV) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision English (EN) (84.25 KB - PDF) First published: 25/03/2026 View Share this page