PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy
Summary of opinion: Daxocox, 12/06/2025 Positive
Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, Onasemnogene abeparvovec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0149/2024
Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0186/2024
EMEA-002999-PIP01-21-M01
PSUSA/00010067/202410
Opinion/decision on a Paediatric investigation plan (PIP): Lynparza, Olaparib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0148/2024
Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0138/2024
Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane,tazobactam, Date of authorisation: 18/09/2015, Revision: 17, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders;Haematology-Hemostaseology, PIP number: P/0137/2024