Human medicines European public assessment report (EPAR): Scemblix, asciminib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Date of authorisation: 25/08/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, Date of authorisation: 14/12/2011, Revision: 19, Status: Authorised

Union Product Database – Product grouping and 3rd country product names Webinar for UPD Industry users, Online, 14:00 - 15:00 Amsterdam time (CEST), from 18/09/2023 to 18/09/2023

Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, Date of authorisation: 13/12/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Imjudo, tremelimumab, Carcinoma, Hepatocellular, Date of authorisation: 20/02/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, Date of authorisation: 26/09/2017, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, Date of authorisation: 01/10/2008, Revision: 17, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,perindopril, decision type: , therapeutic area: , PIP number: P/0376/2022

Orphan designation: Belzupacap sarotalocan, Treatment of uveal melanoma, 13/04/2022,

Orphan designation: (S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one, Treatment of sickle cell disease, 19/10/2020, Positive