Benvenuti sul sito web di Farmacovigilanza

Feed rss AIFA: Notizia

04/04/2025

Chiusura Registro di monitoraggio XALKORI (ALK)

Ultime notizie

11/03/2025

Farmaci imputati nell’esofagite da reflusso

Biblioteca Virtuale per la Salute – Piemonte

02/04/2025

Il contratto di subappalto e le penali contrattuali alla luce del Decreto Correttivo Appalti Pubblici

Agendas and minutes

01/04/2025

Minutes of the CAT meeting 19-21 February 2025

Public consultations

01/04/2025

Reflection paper on a tailored clinical approach in biosimilar development

Regulatory and procedural guidelines (human and veterinary)

04/04/2025

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes

Scientific guidelines (human and veterinary)

31/03/2025

Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

Paediatric investigation plans

02/04/2025

EMEA-002565-PIP02-19-M01

Orphan designations

04/04/2025

Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2025 Positive

New medicines and opinions: human

28/03/2025

Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Status: Opinion

New medicines and opinions: veterinary

14/03/2025

Veterinary medicines European public assessment report (EPAR): Nobilis Multriva IBm+ND+EDS, Infectious Bronchitis, Newcastle disease and Egg Drop Syndrome virus vaccine (inactivated), Status: Opinion