EMEA-003112-PIP01-21-M01

EMEA-000834-PIP01-10-M01

Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Date of authorisation: 21/04/2021, Revision: 12, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0244/2024

Opinion/decision on a Paediatric investigation plan (PIP): Dovato, lamivudine,dolutegravir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0243/2024

Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Date of authorisation: 04/03/2013, Revision: 25, Status: Authorised

EMEA-000836-PIP01-10-M01

Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0255/2024

Opinion/decision on a Paediatric investigation plan (PIP): Bimervax, SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer - XBB.1.16-XBB.1.16 variant,SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0253/2024

Human medicines European public assessment report (EPAR): Datroway, datopotamab deruxtecan, Date of authorisation: 04/04/2025, Revision: 1, Status: Authorised