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

Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 60, Status: Authorised

Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Date of authorisation: 15/11/2013, Revision: 26, Status: Authorised

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