List of signals discussed at PRAC since September 2012

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 - with tracked changes

Comments received from public consultation on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women (EMA/653036/2019)

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

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 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