EMEA-003574-PIP01-24

Opinion/decision on a Paediatric investigation plan (PIP): Recarbrio, imipenem monohydrate,cilastatin sodium,relebactam (MK-7655A), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0190/2024

EMEA-002489-PIP02-24

Opinion/decision on a Paediatric investigation plan (PIP): Steglatro, Ertugliflozin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Metabolism and nutrition disorders, PIP number: P/0189/2024

EMEA-000534-PIP03-17-M01

Human medicines European public assessment report (EPAR): Foclivia, pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), Date of authorisation: 18/10/2009, Revision: 14, Status: Authorised

Orphan designation: Radiprodil Treatment of GRIN-related neurodevelopmental disorder, 22/05/2025 Positive

Orphan designation: Doxorubicin,Liposomal,Pegylated Treatment of soft-tissue sarcoma, 22/05/2025 Positive

Orphan designation: Tranilast Treatment of idiopathic pulmonary fibrosis, 22/05/2025 Positive

Orphan designation: Adeno-associated viral vector serotype 2i8 containing the human LAMP2 isoform B transgene Treatment of Danon disease, 22/05/2025 Positive