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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
Information on taking, submitting and processing samples which potentially contain monkeypox virus.
The CMA investigated the anticipated acquisition by Theramex HQ UK Limited of the European Rights to Viatris’ Femoston and Duphaston Products.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Information for patients, healthcare professionals and developers of new medicines
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
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