Human medicines European public assessment report (EPAR): Tepkinly, epcoritamab, Lymphoma, Large B-Cell, Diffuse, Date of authorisation: 22/09/2023, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Pridopidine hydrochloride, decision type: , therapeutic area: , PIP number: P/0418/2022

Human medicines European public assessment report (EPAR): Enrylaze, crisantaspase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 15/09/2023, Status: Authorised

Human medicines European public assessment report (EPAR): Kimmtrak, tebentafusp, Uveal Neoplasms, Date of authorisation: 01/04/2022, Revision: 1, Status: Authorised

Qualification of novel methodologies for medicine development

Qualification of novel methodologies for drug development: guidance to applicants

Human medicines European public assessment report (EPAR): Colobreathe, colistimethate sodium, Cystic Fibrosis, Date of authorisation: 13/02/2012, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid,colecalciferol, Osteoporosis, Postmenopausal, Date of authorisation: 16/10/2009, Revision: 18, Status: Authorised

Withdrawn application: Gazyvaro, obinutuzumab, Date of withdrawal: 04/07/2023, Post-authorisation

Human medicines European public assessment report (EPAR): Fosavance, alendronic acid,colecalciferol, Osteoporosis, Postmenopausal, Date of authorisation: 24/08/2005, Revision: 27, Status: Authorised