Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 24 February 2025 to 28 February 2025
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 27 January 2025 to 31 January 2025
Agenda of the CHMP meeting 11-14 November 2024
Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting, Online, Rome, Italy, Broadcast, from 15 November 2024, 09:00 (CET) to 15 November 2024, 17:00 (CET)
Highlights – sixth EMA/EuropaBio bilateral meeting
Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2024
Veterinary medicines European public assessment report (EPAR): Convenia, cefovecin, Status: Authorised
Veterinary medicines European public assessment report (EPAR): Cepedex, dexmedetomidine, Status: Authorised
Veterinary medicines European public assessment report (EPAR): Cardalis, benazepril hydrochloride,spironolactone, Status: Authorised
Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene Treatment of X-linked chronic granulomatous disease, 09/02/2012 Positive