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Prescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo…
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
List of Field Safety Notices from 13 to 17 May 2024.
Advise patients that naltrexone/bupropion has been associated with adverse reactions such as dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks. Advise patients not…
Funding of £85 million will be announced at a global event to support the international community in tackling the growing threat of antimicrobial resistance.
First published during the 2022 to 2024 Sunak Conservative government
The Medicines and Healthcare products Regulatory Agency (MHRA) is advising anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health profe…
Public Assessment Report of review of Topiramate safety data and expert advice on management of risks.
In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.
Keep up to date with the latest information from the UK GLP monitoring authority.
A skin cream claiming to be a natural Chinese herbal remedy for treating eczema, contains a potentially harmful steroid and should not be used, warns the Medicines and Healthcare products Regulatory Agency (MHRA).
A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep…
Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.
Pharmacovigilance system requirements
TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mi…
Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is…
This guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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