Opinion/decision on a Paediatric investigation plan (PIP): Toripalimab, decision type: , therapeutic area: , PIP number: P/0408/2022

Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,valsartan, decision type: , therapeutic area: , PIP number: P/0387/2022

Opinion/decision on a Paediatric investigation plan (PIP): Dimeric protein comprised of two disulfide-linked monomers, each being a fully human fusion protein consisting of a modified extracellular domain of the human activin receptor type IIA fused to the fragment crystallizable domain of human IgG1 Fc including the hinge region, CH2 and CH3 domains (KER-050), decision type: , therapeutic area: , PIP number: P/0407/2022

Opinion/decision on a Paediatric investigation plan (PIP): Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11), decision type: , therapeutic area: , PIP number: P/0361/2022

Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023, European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2023 to 14/09/2023

Kevzara (sarilumab) supply shortage

Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS, Online, from 15/09/2023 to 15/09/2023

Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2;Heart Failure;Renal Insufficiency, Chronic, Date of authorisation: 22/05/2014, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR): Victoza, liraglutide, Diabetes Mellitus, Type 2, Date of authorisation: 30/06/2009, Revision: 23, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Brintellix,Vortioxetine, decision type: , therapeutic area: , PIP number: P/0337/2022