Publication #8280

Reference
Drug alert 43/2024
Name
Drug Alert Class 4 Drug Alert 43 2024 – Class 4 medicines defect information – caution in use – Sandoz Ltd – Risperidone 1mg, 2mg and 3mg
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Department
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets. The PIL and SmPC does not include the Adverse event of Stevens Johnson’s syndrome and toxic epidermal necrolysis in section 4.8 Adverse drug reactions for the MedDRA System Organ Class ‘Skin and subcutaneous tissue disorders’. 

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-09-26 08:37:00


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