Human medicines European public assessment report (EPAR): Lonsurf, trifluridine,tipiracil, Date of authorisation: 25/04/2016, Revision: 10, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Recarbrio, relebactam (MK-7655A),cilastatin sodium,imipenem monohydrate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0090/2023

EMEA-001744-PIP01-14-M02

Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol,drospirenone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0071/2023

Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology;Oncology, PIP number: P/0079/2023

EMEA-003171-PIP01-21

EMEA-003218-PIP01-22

EMEA-003237-PIP01-22

EMEA-001371-PIP03-22

Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Pembrolizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0096/2023