Based on monitoring of the official EMA website and the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) during September 2025, the Center recommends that registration certificate holders amend the instructions for medical use of medicinal products with the following active substances:
Enzalutamide, Digoxin
Information on the interference with laboratory test results that causes falsely elevated digoxin levels under the influence of enzalutamide must be reflected in the instructions for medical use of medicinal products containing enzalutamide as well as those containing digoxin. For details, see the link https://surl.li/zpwnyn
Dexketoprofen (dexketoprofen)
The instructions for medical use of medicinal products for systemic use should be updated by adding a warning about Kounis syndrome, as well as by adding fixed drug eruption and Kounis syndrome as adverse reactions with the frequency “not known”.
The instructions for medical use of medicinal products for topical use should be updated by adding contraindications and recommendations regarding use during pregnancy. For details, see https://surl.li/yjlofa
Clozapine (clozapine)
Review the current blood monitoring recommendations in order to reduce the risk of agranulocytosis, and specify particular threshold values for the subpopulation with benign ethnic neutropenia (BEN). Amend the sections “Special warnings and precautions for use”, “Method of administration and doses”, “Adverse reactions”, “Interaction with other medicinal products and other forms of interaction” in accordance with the specified recommendations https://surl.li/stqzif
Vaccines for the prevention of varicella; measles, mumps, rubella and varicella (live)
Make changes to the relevant parts of the sections “Special warnings and precautions for use” and “Adverse reactions” taking into account the risk of encephalitis. For more details, see the link https://surl.li/fmzzya
Isoniazid (isoniazid)
Add a warning about severe cutaneous adverse reactions, as well as acute generalized exanthematous pustulosis and lupus-like syndrome, as adverse reactions with the frequency “not known”. For details, follow the link https://surl.li/dlrrsf
The benefit/risk ratio of medicinal products remains unchanged provided the proposed changes to the instructions for medical use are made.
