其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules are missing the medicines legal classification for a Prescription Only Medicine ‘POM’. There is no risk to product quality or safety of the medicines because of this missing information, therefore the affected batches are not being recalled. For details of the affected batch numbers, please refer to the website in MHRA.
Pregabalin Jubilant is indicated for the treatment of peripheral and central neuropathic pain, and generalised anxiety disorder. It is also indicated as adjunctive therapy in partial seizures with or without secondary generalization.
Healthcare professionals are advised to exercise caution when handling the affected products and ensure that they are stored accordingly and in line with the guidance for the storage of Prescription Only Medicines (POM). Additionally, healthcare professionals are reminded to only dispense these products when the pharmacy team receives a suitable prescription prescribed by a qualified health professional.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-pregabalin-25mg-50mg-75mg-100mg-150mg-200mg-225mg-300mg-capsules-jubilant-pharmaceuticals-nv-el-25-a-slash-19
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Apr 30, 2025
Issued at HKT 17:45
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