Nitrosamines Safety Operational Expert Group

PSUSA/00000464/202407

Agenda of the CAT meeting 14-16 April 2025

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 51, Status: Authorised

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025, 09:00 (CEST) to 2 April 2025, 15:50 (CEST)

Minimum inhibitory concentration (MIC) breakpoints

Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline

Human medicines European public assessment report (EPAR): Rezolsta, darunavir,cobicistat, Date of authorisation: 19/11/2014, Revision: 18, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously Orbactiv), oritavancin (diphosphate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0074/2024

Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0076/2024