Triumeq-H-C-PSUSA-00010075-202301 : EPAR Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Human medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant, Date of authorisation: 09/12/2022, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Prevenar 13, pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed), Pneumococcal Infections;Immunization, Date of authorisation: 09/12/2009, Revision: 45, Status: Authorised

Human medicines European public assessment report (EPAR): Kivexa, abacavir,lamivudine, HIV Infections, Date of authorisation: 16/12/2004, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR): Apexxnar, pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Pneumococcal Infections, Date of authorisation: 14/02/2022, Revision: 6, Status: Authorised

Kivexa-H-C-PSUSA-00000011-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Landiolol : List of nationally authorised medicinal products - PSUSA/00010570/202302

Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Date of authorisation: 19/11/2007, Revision: 45, Status: Authorised

Human medicines European public assessment report (EPAR): Somavert, pegvisomant, Acromegaly, Date of authorisation: 12/11/2002, Revision: 28, Status: Authorised

Second bilateral meeting between European Medicines Agency (EMA) and Vaccines Europe, European Medicines Agency, Amsterdam, the Netherlands, from 27/11/2023 to 27/11/2023