Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk

Archive of development of good pharmacovigilance practices

Fees for veterinary medicines

Fees for human medicines

Highlights – 1st European Medicine Agency (EMA) and European Respiratory Society (ERS) bilateral meeting

Human medicines European public assessment report (EPAR): Bildyos, denosumab, Date of authorisation: 17/09/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Tepkinly, epcoritamab, Date of authorisation: 22/09/2023, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Date of authorisation: 14/08/1997, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, Date of authorisation: 19/09/2024, Revision: 3, Status: Authorised