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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).
Information about the risks of taking valproate medicines during pregnancy.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
Anastrozole is now authorised as a preventative treatment for post-menopausal women at moderate or high risk of breast cancer.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
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.
Guidance for prescribing vets on the use of the cascade.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
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...
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, patients, parents and carers should be aware of the signs and symptoms...
Information for those who have been prescribed Paxlovid.
Evidence-based recommendations to protect first responders from exposure to fentanyl.
MHRA is asking for feedback on proposals to change the legal classification of Otrivine extra dual relief nasal spray solution from prescription only medicine (POM) to pharmacy only (P).
How a marketing authorisation holder should report a defect with a veterinary medicine.
Veterinary products seized during an FDA (US Food and Drug Administration) Operation.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Product Safety Report for Esapharma Movate Steroid Cream presenting a serious chemical risk.
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