In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must make amendments to 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 about the medicinal product corresponds to current scientific knowledge.
The Netherlands Pharmacovigilance Center announced that the information on medicinal products containing mebendazole (mebendazole) will be updated by adding information on the risk of fever.
Mebendazole is an anthelmintic agent indicated for the treatment of infestations caused by helminths, such as pinworms and roundworms.
The Netherlands Pharmacovigilance Centre (Lareb) received and reviewed 23 reports of fever following the use of mebendazole. Based on the analysis of individual safety reports and other sources of information, the association between the use of mebendazole and pyrexia was considered plausible.
Lareb informed the Netherlands Medicines Evaluation Board (MEB) of these reports, and the MEB contacted the holders of registration certificates of medicinal products containing mebendazole and recommended adding information about fever to the instructions for medical use.
TO ANALYZE THE PUBLISHED INFORMATION, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
