In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The European Medicines Agency (EMA) published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on July 7–10, 2025. Following the review, PRAC did not initiate safety-related changes to the registration materials/instructions for medical use of medicinal products containing levamisole. However, PRAC identified the need to obtain additional information from the registration certificate holder (RCH) with the aim of further assessing the safety profile and the benefit/risk ratio.
Levamisole hydrochloride (levamisole hydrochloride) – PSUSA/00001845/202501
Levamisole is an anthelmintic medicinal product and is indicated for the treatment of infestations caused by the following species of intestinal helminths: Ascaris lumbricoides, Necator americanus, Ancylostoma duodenale.
Summary of recommendations and conclusions
- The PRAC presented conclusions prepared on the basis of the preliminary assessment report, pointing to serious concerns regarding the benefit/risk balance of medicinal products containing levamisole, for the approved indications.
- The PRAC considers that the RCH Gedeon Richter must provide additional data on the risk of leukoencephalopathy, including a concise analysis of the impact of this risk on the benefit/risk balance of medicinal products containing levamisole, taking into account all available information, and must also propose effective risk minimization measures to reduce this risk in the approved indications. In addition, the RCH Gedeon Richter must provide information on the extent of off-label use of the medicinal product in various therapeutic areas, as well as on cases of misuse and related safety issues.
- PRAC will assess the responses provided after their submission by the registration certificate holder. PRAC will adopt a recommendation for the CMDh at the plenary meeting in September 2025.
Перелік лікарських засобів, що містить левамізол (levamisole) та дозволені до медичного застосування в Україні (за даними Державного реєстру лікарських засобів станом на 17.11.2025).
THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE LINK TO ANALYZE THE PUBLISHED INFORMATION:
