Opinion/decision on a Paediatric investigation plan (PIP): Omvoh, Mirikizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0534/2023

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Immune system disorders, PIP number: P/0531/2023

Implementation strategy of ICH Guideline M12 on drug interaction studies

Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate,vaborbactam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0530/2023

Antimicrobial Sales and Use (ASU) Platform: Release notes

Human medicines European public assessment report (EPAR): Dafiro HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Date of authorisation: 03/11/2009, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine,valsartan,hydrochlorothiazide, Date of authorisation: 03/11/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Exforge HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Date of authorisation: 15/10/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), lonapegsomatropin, Date of authorisation: 11/01/2022, Revision: 5, Status: Authorised

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance