EU Innovation Network (EU-IN)

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations, European Medicines Agency, Amsterdam, the Netherlands, from 14/11/2023 to 15/11/2023

Human medicines European public assessment report (EPAR): Imatinib Koanaa, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome;Dermatofibrosarcoma;Gastrointestinal Stromal Tumors, Date of authorisation: 22/09/2021, Status: Withdrawn

Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, COVID-19 virus infection, Date of authorisation: 28/01/2022, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Veklury, remdesivir, COVID-19 virus infection, Date of authorisation: 03/07/2020, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris), macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Revision: 3, Status: Authorised

DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline

Human medicines European public assessment report (EPAR): Briumvi, ublituximab, Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Date of authorisation: 31/05/2023, Revision: 01, Status: Authorised

Timetable: Annual reassessment - ATMP

Timetable: Annual renewal application of conditional marketing authorisation - ATMP