February 21, 2026
At its January 2026 meeting, PRAC adopted important new safety information concerning three distinct medicinal products: cefazolin (and cefazolin with lidocaine), erdatinib, and pegylated liposomal doxorubicin.
At its January 2026 meeting, PRAC adopted important new safety information concerning three distinct medicinal products: cefazolin (and cefazolin with lidocaine), erdatinib, and pegylated liposomal doxorubicin.
Based on the EMA Guideline on Good Pharmacovigilance Practices (GVP) Chapter P.III – Product- or Population-Specific Considerations III
Medical overview of childhood cancer, with special emphasis on drug-induced adverse reactions, including the rarely discussed topic of therapy-related secondary cancers, and their management from a pharmacovigilance perspective.
From a pharmacovigilance standpoint, drug-induced anaemia is a significant and often under-recognized adverse drug reaction (ADR). It can occur through various mechanisms, and early detection is crucial to prevent morbidity and mortality.
The Egyptian Drug Authority (EDA) has established a structured framework for managing variations to pharmaceutical products in the post-marketing phase. The document titled Administrative & Relevant Documents & Time frame for human pharmaceutical variations (Version 1/2026, Code NP. CAPP.109) serves as a critical guideline for applicants seeking to modify registered medicinal products.
New Zealand's Medsafe provides clear guidelines outlining the responsibilities and processes for ensuring participant safety during clinical investigations of both medicines and medical devices.
The signals include a new safety concern for Kounis syndrome with cefazolin and epiphysiolysis with erdafitinib and a rare renal adverse event with pegylated liposomal doxorubicin. In addition, PRAC requested supplementary information for several other signals, including strabismus with atropine eye drops, angioedema with darolutamide, DRESS syndrome with oxacillin, acute pancreatitis with vortioxetine,...
Advancing Medication Safety Through Knowledge and Vigilance
