Human medicines European public assessment report (EPAR): Deferasirox Accord, deferasirox, Iron Overload;beta-Thalassemia, Date of authorisation: 09/01/2020, Revision: 5, Status: Authorised

Guidance on paediatric submissions

Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic;Arthritis, Rheumatoid;Psoriasis, Date of authorisation: 13/01/2016, Revision: 21, Status: Authorised

Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

Opinion/decision on a Paediatric investigation plan (PIP): Suvecaltamide (hydrochloride), decision type: , therapeutic area: , PIP number: P/0372/2022

Opinion/decision on a Paediatric investigation plan (PIP): Golidocitinib, decision type: , therapeutic area: , PIP number: P/0386/2022

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