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Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary. Patients with diabetes may experience symptomatic hypoglycaemia if diabetic...
INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during treatment.
All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk of hepatitis B reactivation, and should be...
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...
Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are available for dabigatran (Praxbind▼, idarucizumab), and apixaban and rivaroxaban (Ondexxya▼, andexanet alfa)....
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)’
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
The MHRA has published advice for patients and healthcare professionals
How investigators and sponsors should manage clinical trials during COVID-19
Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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