Fifth Industry Standing Group (ISG) meeting, European Medicines Agency, Amsterdam, the Netherlands, from 26/06/2023 to 26/06/2023

Fifth European Medicines Agency - EuropaBio bilateral meeting, Virtual meeting, from 06/07/2023 to 06/07/2023

Lamotrigine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001825/202211

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/202211

Human medicines European public assessment report (EPAR): Ledaga, chlormethine, Mycosis Fungoides, Date of authorisation: 03/03/2017, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Abiraterone Mylan, abiraterone acetate, Prostatic Neoplasms, Date of authorisation: 20/08/2021, Revision: 4, Status: Authorised

Orphan designation: Lentiviral vector carrying the Fanconi anaemia-A (FANCA) gene, Treatment of Fanconi anaemia type A, 17/12/2010, Positive

Human medicines European public assessment report (EPAR): Lonsurf, trifluridine,tipiracil, Colorectal Neoplasms, Date of authorisation: 25/04/2016, Revision: 9, Status: Authorised

Composition of the Emergency Task Force (ETF) for preparedness

Orphan designation: 2',3',5'-Tri-O-acetyluridine, Treatment of 5-fluorouracil overdose, 15/05/2009, Positive