Opinion/decision on a Paediatric investigation plan (PIP): Livmarli, Maralixibat chloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0488/2023

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0513/2023

Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0439/2023

Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 60, Status: Authorised

New fee regulation: webinar for human industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 October 2024, 10:30 (CEST) to 24 October 2024, 11:30 (CEST)

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 49, Status: Authorised

New chair elected for EMA’s Orphan Medicinal Products Committee

Organisation chart: Human Medicines

Human Medicines

Orphan designation: N-[(1R)-1-[(S)-(2-Chloro-3-fluorophenyl)hydroxymethyl]butyl]-7-fluoro-2,3-dihydro-2-oxo-1H-indole-4-carboxamide Treatment of congenital alpha-1 antitrypsin deficiency, 25/07/2024 Positive