Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40

Levetiracetam Neuraxpharm 250mg granules for oral solution in sachet

Levetiracetam Neuraxpharm 500mg granules for oral solution in sachet

Levetiracetam Neuraxpharm 750mg granules for oral solution in sachet

Levetiracetam Neuraxpharm 1000mg granules for oral solution in sachet

Levetiracetam Neuraxpharm 1500mg granules for oral solution in sachet

Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.

Currently all available stock is impacted. Following discussions between the MHRA and the Department of Health and Social Care, these products have been considered critical for patients who are unable to take tablet formulations and rely on this dosage form. Therefore, the affected batches will continue to be supplied without repackaging and are included in this notification.

A corrected version of the Patient Information Leaflet, containing the required information, is not yet available on the MHRA Products website. Neuraxpharm Limited have confirmed that all packs of Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet distributed from June 2027 will contain an updated and correct PIL.

Healthcare professionals are advised that the current Patient Information Leaflet (PIL) for Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet does not contain all the information included in the corresponding reference product information.

1. Healthcare professionals, including GPs, independent prescribers and specialist prescribers, involved in prescribing Levetiracetam should continue to prescribe and dispense Levetiracetam Neuraxpharm in accordance with the approved product information and manage patients according to their individual clinical circumstances.