Opinion/decision on a Paediatric investigation plan (PIP): rivaroxaban,Acetylsalicylic acid, W: decision granting a waiver in all age groups for all conditions or indications, P/0042/2023 Opinion/decision on a Paediatric investigation plan (PIP): setanaxib, W: decision granting a waiver in all age groups for all conditions or indications, P/0032/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tetanus toxoid, W: decision granting a waiver in all age groups for all conditions or indications, P/0043/2023

Opinion/decision on a Paediatric investigation plan (PIP): diclofenac,orphenadrine (citrate), W: decision granting a waiver in all age groups for all conditions or indications, P/0036/2023 Human medicines European public assessment report (EPAR): Vyvgart, Efgartigimod alfa, Myasthenia Gravis,, ,, 4, Authorised (updated) Opinion/decision on a Paediatric investigation plan (PIP): Garadacimab, PM: decision on the application for modification of an agreed PIP, P/0048/2023 (updated) Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia,, , 2, Authorised (updated) Opinion/decision on a Paediatric investigation plan (PIP): Exagamglogene autotemcel, PM: decision on the application for modification of an agreed PIP, P/0046/2023 (updated) Opinion/decision on a Paediatric investigation plan (PIP): Respiratory syncytial virus stabilised prefusion F subunit vaccine, PM: decision on the application for modification of an agreed PIP, P/0058/2023 (updated) Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative Crohn Disease,, 25, Authorised (updated) Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup B fHbp subfamily A,Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis serogroup B fHbp subfamily B,Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein,Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY), PM: decision on the application for modification of an agreed PIP, P/0055/2023 (updated) Opinion/decision on a Paediatric investigation plan (PIP): Evoncabtagene pazurgedleucel, PM: decision on the application for modification of an agreed PIP, P/0016/2023 (updated) Opinion/decision on a Paediatric investigation plan (PIP): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab), PM: decision on the application for modification of an agreed PIP, P/0017/2023 (updated) Opinion/decision on a Paediatric investigation plan (PIP): Methylphenidate (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0057/2023 (updated) , European Medicines Agency, Amsterdam, 09:30 - 13:30 (CET), from to (updated) News and press releases: Getting ready for EMA’s website relaunch on 5 December 2023 Opinion/decision on a Paediatric investigation plan (PIP): Obefazimod, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0519/2022

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