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Guidance on what approved bodies are, what they do and how you can become one.
Some patients may have exacerbation or rebound symptoms of rosacea. It is important to initiate treatment with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
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 curren…
Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
This advice has been written by the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) at the request of the Medicines and Healthcare products Regulatory Agency (MHRA – UK regulator). It is in the …
MHRA good clinical practice (GCP) metrics reports of compliance issues.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
The Medicines and Healthcare products Regulatory Agency is moving to Canary Wharf in June 2018.
List of Field Safety Notices from 25 to 29 March 2024.
Letters requesting a set of regulators to update their strategic approach to AI, with the intention of increasing the transparency around how they are implementing the AI Regulation White Paper proposals.
First published during the 2022 to 2024 Sunak Conservative government
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
New measures strengthen the safe use of the acne drug isotretinoin for patients across the UK, following a patient-focused expert review
Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses. Women of childbearing potential should use effective contracep…
Apply for a public health exemption from the sunset clause.
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb…
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