Based on monitoring of the official EMA website on medicine safety during July 2025, the Center recommends that registration certificate holders make changes to the instructions for medical use of products with the following active substances:
Vortioxetine (vortioxetine)
Add to the “Adverse reactions” section, subsection “Psychiatric disorders”, hallucinations with frequency “uncommon”. More details at: https://surli.cc/zwmpoz
Meropenem (meropenem)
Add a warning about liver injury induced by medicinal products (DILI), hypokalemia and DILI (including hepatitis and hepatic failure) to the sections “Special warnings and precautions for use” and “Adverse reactions” with the frequency “uncommon”. For details, see the link https://surl.li/oyqqse
Diclofenac (diclofenac) for systemic use
Amend the existing warning on skin reactions by adding generalized bullous fixed drug eruption and fixed drug eruption to the sections “Special warnings and precautions for use” and “Adverse reactions” with the frequency “not known.” For details, see the link https://surl.li/rsldos
Abrocitinib (abrocitinib)
Add neutropenia as an adverse reaction with the frequency “uncommon”. More details at the link https://surl.li/hnefag
Loxapine (loxapine)
Add a warning about the risk of drug-induced eosinophilia with systemic symptoms (DRESS). More details at the link https://surl.li/woivnn
Pembrolizumab (pembrolizumab)
Add a warning regarding immune-mediated adverse reactions in patients with existing autoimmune diseases. More details at https://surl.lu/wyeseh
