EMEA-002907-PIP01-20-M03

EMEA-002705-PIP01-19-M02

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/0218/2024

EMEA-002093-PIP02-17-M02

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: Immune system disorders;Surgical and medical procedures, PIP number: P/0217/2024

Opinion/decision on a Paediatric investigation plan (PIP): Tecartus, brexucabtagene autoleucel, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps);Oncology, PIP number: P/0221/2024

Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Date of authorisation: 09/11/2017, Revision: 12, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Sunlenca, Lenacapavir sodium, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0271/2024

Human medicines European public assessment report (EPAR): Imuldosa, ustekinumab, Date of authorisation: 12/12/2024, Revision: 3, Status: Authorised

EMEA-002827-PIP01-20-M03