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List of Field Safety Notices from 22 to 26 April 2024.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
How a marketing authorisation holder should report a defect with a veterinary medicine.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
Guidance and support on coronavirus (COVID-19) in Scotland.
Information on the reporting, investigation and management of acute flaccid paralysis (AFP) and acute flaccid myelitis (AFM).
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
Check what side effects people have reported when they've taken a medicine.
Protocols and procedures for testing the value for cultivation or use (VCU) of agricultural crops.
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.
How to use a cost effectiveness analysis to evaluate your digital health product.
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
Advice to give pregnant women on infections that can be transmitted via contact with animals that are or have recently given birth.
Check the tariff classification for peptide nisin standardised with sodium chloride
Guidance on acetic acid (also known as ethanoic acid) for use in responding to chemical incidents.
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