Development and manufacture of oligonucleotides - Scientific guideline

Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0114/2023

Opinion/decision on a Paediatric investigation plan (PIP): Jyseleca, filgotinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0113/2023

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0148/2023

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0147/2023

Opinion/decision on a Paediatric investigation plan (PIP): Saphnelo, anifrolumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0149/2023

Opinion/decision on a Paediatric investigation plan (PIP): Sivextro, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0112/2023

Human medicines European public assessment report (EPAR): Luveris, lutropin alfa, Date of authorisation: 29/11/2000, Revision: 22, Status: Authorised

Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA

Agenda of the HMPC meeting 22-24 July 2024