On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services
Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0099/2024
Opinion/decision on a Paediatric investigation plan (PIP): Supemtek Tetra (previously Supemtek), recombinant Influenza Hemagglutinin-strain A (H1N1 subtype),recombinant Influenza Hemagglutinin-strain A (H3N2 subtype),recombinant Influenza Hemagglutinin-strain B (Victoria lineage),recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0098/2024
EMEA-003220-PIP01-22-M01
EMEA-003215-PIP01-22-M01
NovoSeven (eptacog alfa)
PSUSA/00000795/202410
Highlights - Second EMA / Alliance for Regenerative Medicine bilateral meeting
Orphan designation: defibrotide Prevention of hepatic veno-occlusive disease, 29/07/2004 Withdrawn
Orphan designation: defibrotide Prevention of graft-versus-host disease, 13/11/2013 Withdrawn