EMA/PE/0000221589
EMA/PE/0000221589
EMA/PE/0000221589
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000238005
Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000238074
Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: EMA/PE/0000182362
EMA/PE/0000221709
Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0391/2023
Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0492/2023
Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU - Scientific guideline
Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU
Human medicines European public assessment report (EPAR): Denosumab Intas, denosumab, Date of authorisation: 17/11/2025, Status: Authorised