Withdrawn application: Tecentriq, 06/09/2024

Superseded community herbal monograph on Rosmarinus officinalis L., aetheroleum

Summary of opinion: Imvanex, 19/09/2024 Positive

EMA recommends extending indication of mpox vaccine to adolescents

Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0073/2022

Opinion/decision on a Paediatric investigation plan (PIP): Brintellix, Vortioxetine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: P/0337/2022

Opinion/decision on a Paediatric investigation plan (PIP): Relvar Ellipta, vilanterol,fluticasone furoate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0092/2021

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0002/2023

Opinion/decision on a Paediatric investigation plan (PIP): Zinplava, Bezlotoxumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0135/2022

EMEA-003189-PIP01-22-M01