Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators
Opinion/decision on a Paediatric investigation plan (PIP): Leqvio,Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0495/2022
Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa,Isatuximab, decision type: , therapeutic area: , PIP number: P/0494/2022
Opinion/decision on a Paediatric investigation plan (PIP): Setrusumab, decision type: , therapeutic area: , PIP number: P/0536/2022
Opinion/decision on a Paediatric investigation plan (PIP): Imvanex,Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox), decision type: , therapeutic area: , PIP number: P/0539/2022
Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline
Overview of comments received on 'Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy'
Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline
HMPC: overview of assessment work - priority list
EMA multi-stakeholder workshop on qualification of novel methodologies, Online, from 17/04/2023 to 18/04/2023