Ketoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limits

Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methods

Referral: Mysimba, naltrexone,bupropion Article 20 procedures Under evaluation, 30/04/2024

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Bimzelx, bimekizumab, Date of authorisation: 20/08/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation: 28/05/2015, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 22, Status: Authorised

Guidebook for tenderers

Human medicines European public assessment report (EPAR): Bydureon, exenatide, Date of authorisation: 17/06/2011, Revision: 26, Status: Authorised

List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)