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Medicines and Healthcare products Regulatory Agency
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Decisions made by MHRA following investigations into complaints about advertising for licensed medicines.
Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered.
Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses.
If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment.
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement).
Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products. Class 2 medicines recalls were issued for batches of irbesartan/hydrochlorothiazide and irbesartan tablets.
Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).
Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019
Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
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.
List of sites granted a manufacturer or wholesale dealer licence
A Teesside man has been subjected to a confiscation order after a 2018 conviction for wholesale distribution and supply, and possession of medicinal products and money laundering.
Today at Aylesbury Crown Court Keith Morgan of Milton Keynes was sentenced for illegally selling or supplying prescription-only medicine and unauthorised medicine.
Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze.
An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) met yesterday at the Medicines and Healthcare products Regulatory Agency (MHRA) to begin the review of the benefits and risks of opioid medicines, including dependence and addiction.
We are working with pharmacies to recall Irbesartan containing medication as the investigation uncovers more affected products.
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