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The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Guidance for industry and organisations to follow from 1 January 2021.
Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont…
If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).
Healthcare professionals may have more responsibility to accurately prescribe an unlicensed medicine or an off-label medicine than when they prescribe a medicine within the terms of its licence.
The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
Marketing authorisations (MAs) granted since January 2014.
New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati…
Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Statement from the Medicines and Healthcare products Regulatory Agency on Allergan suspending sales of textured breast implants and tissue expanders in Europe.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
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