MHRA Issues Class 4 Defect Notification to Neuraxpharm UK

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information. Neuraxpharm UK Limited Active Ingredient: levetiracetam SNOMED code: 42426311000001104 Active Ingredient: levetiracetam SNOMED code: 42426611000001109 Active Ingredient: levetiracetam SNOMED code: 41543411000001107 Active Ingredient: levetiracetam SNOMED code: 42426811000001108 Active Ingredient: levetiracetam SNOMED code: 41544811000001107 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. Healthcare Professionals should be informed: The following text has been included from other brands of levetiracetam products (reference product) that contain the correct information and indicate what sections will be updated in due course: 2.Healthcare professionals involved in dispensing the impacted products, including pharmacy teams are advised to review the information contained within this notification and take this into account when dispensing this product. a. Where possible, patients should be provided a copy of the supplementary letter detailing the missing information from the PIL with each subsequent dispensing activity. A copy of the supplementary letter can also be found by scanning the below QR code. b. There is no expectation that patients should be contacted retrospectively, however if patients present with specific symptoms they should be referred to the appropriate healthcare professional. Additionally, Neuraxpharm Limited will provide a copy of the supplementary letter with each future delivery so that this can be provided to patients directly when the product is dispensed. To request hard copies of the supplementary letter, please contact Medinfo-uk@neuraxpharm.com , or telephone +44 (0) 330 128 0919 with your details, i.e. name, address, required number of supplementar