Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol,mometasone, Asthma, Date of authorisation: 30/05/2020, Revision: 6, Status: Authorised

Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline

Summary of opinion: Brukinsa,zanubrutinib, 12/10/2023, Positive

Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid,(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide, decision type: , therapeutic area: , PIP number: P/0503/2022

Opinion/decision on a Paediatric investigation plan (PIP): Jcovden (previously COVID-19 Vaccine Janssen),COVID-19 vaccine (Ad26.COV2-S (recombinant)), decision type: , therapeutic area: , PIP number: P/0542/2022

Opinion/decision on a Paediatric investigation plan (PIP): Durlobactam / sulbactam (SUL-DUR), decision type: , therapeutic area: , PIP number: P/0476/2022

Opinion/decision on a Paediatric investigation plan (PIP): Gadoquatrane (BAY 1747846), decision type: , therapeutic area: , PIP number: P/0500/2022

Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta,Ofatumumab, decision type: , therapeutic area: , PIP number: P/0537/2022

Opinion/decision on a Paediatric investigation plan (PIP): Oxbryta,Voxelotor, decision type: , therapeutic area: , PIP number: P/0491/2022

Risk management plans (RMP) in post-authorisation phase: questions and answers