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What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and a reminder of a recent MHRA National Patient Safety Alert to highlight the potential risk of underdosing with calcium gluconate in severe hyperkalaemia....
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
The Medicines and Healthcare products Regulatory Agency is moving to Canary Wharf in June 2018.
Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.
Warning that thermal cameras and other such “temperature screening” products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus.
Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
Reporting suspected side effects or incidents to the Yellow Card scheme supports the safe use of medical products for everyone
People who have bought ZeniPower mercury-free hearing aid batteries to check the best before date on the packs due to two defective batches.
(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)
MHRA can place UK at the forefront of a global drive to improve public health according to Triennial Review.
Information for patients, healthcare professionals and developers of new medicines
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
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