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Data, Freedom of Information releases and corporate reports
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
The CAT has unanimously upheld the level of penalty imposed by the CMA for a market sharing agreement relating to 20mg hydrocortisone tablets.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod (Velsipity) to treat people with moderately to severely active ulcerative colitis.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the current advice to ensure that all patients with renal impairment...
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The review of the safety of isotretinoin has concluded.
Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
The penalties if you are caught taking or dealing drugs - drug classification, fines and prison sentences
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date.
Information for health professionals on the epidemiology, transmission and prevention of Chlamydia abortus which can cause stillbirth or abortion in humans.
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