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The review of the safety of isotretinoin has concluded.
Standard: Category lists following implementation of the Windsor Framework
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Field Safety Notices: 13 to 17 October 2025
List of Field Safety Notices from 13 to 17 October 2025.
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.
Paracetamol and pregnancy – reminder that taking paracetamol during pregnancy remains safe
Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at the lowest dose and for the shortest duration. It also acts as an antipyretic and is therefore used to treat fever.
Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
