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 Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of periodic safety update reports (PSURs) for medicinal products containing albendazole, PSUSA/00000073/202507, reached the following conclusions.
In view of the available data on hepatitis from spontaneous reports, which in some cases indicate a close temporal relationship, and in view of the plausible mechanism of action, PRAC considers that a causal relationship between the use of albendazole and hepatitis is at least reasonably possible. PRAC concluded that the instructions for medical use of medicinal products containing albendazole should be amended accordingly.
Having considered the PRAC recommendations, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the overall conclusions of the PRAC and the grounds for the recommendations.
Based on the scientific conclusions on albendazole, the CMDh considers that the benefit/risk balance of medicinal products containing albendazole remains unchanged, provided that the proposed amendments are made to the instructions for medical use.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
Treatment of intestinal forms of helminthiasis and cutaneous larva migrans syndrome with low doses in a short course:
“Special precautions for use” section
The following warning should be added:
Effect on liver enzyme levels
The use of albendazole has been associated with mild to moderate elevations in liver enzyme levels. Cases of hepatitis have also been reported. Liver enzyme values usually return to normal after treatment is discontinued. Patients with hepatic impairment should consult a doctor before starting treatment.
“Adverse reactions” section
The following adverse reaction should be added to the System Organ Class (SOC) “Hepatobiliary disorders” with the frequency “uncommon”:
hepatitis
Changes to the safety information of medicinal products containing albendazole, following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 09 – 12 February 2026
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on February 09 – 12, 2026. Following the meeting, a decision was made that safety-related changes need to be introduced to the registration materials/instructions for medical use of medicinal products containing albendazole.
Albendazole (albendazole) – PSUSA/00000073/202507
Albendazole – an antiprotozoal and anthelmintic medicinal product from the benzimidazole carbamate group, indicated for the treatment of intestinal forms of helminthiasis, cutaneous Larva Migrans syndrome, as well as tissue helminthiases.
Based on the assessment of Periodic Safety Update Reports (PSURs), the PRAC reviewed the benefit/risk balance of medicinal products containing albendazole and made the relevant recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of medicinal products containing albendazole (albendazole), for the approved indications remains unchanged.
- At the same time, the instructions for medical use should be updated by adding hepatitis to the list of warnings and adverse reactions with the frequency “uncommon”. Accordingly, the existing provisions of the instructions for medical use must be amended1.
- In the next PSUR, all registration certificate holders must continue to monitor cases of neurological disorders, including encephalopathy, as well as blood and lymphatic system disorders, paying particular attention to cases of hypereosinophilia.
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1Update of the “Special warnings and precautions for use” and “Adverse reactions” sections of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to CMDh for decision.
List of medicinal products containing albendazole and approved for medical use in Ukraine (according to the State Register of Medicinal Products as of 28.05.2026). (15 KB) (Downloaded: 09.06.2026 05:57:06)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
