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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 contraception during treatment with carbimazole.
If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment. Re-exposure to carbimazole may result in life-threatening acute pancreatitis with a decreased time to onset.
Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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...
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
List of Field Safety Notices from 22 to 26 April 2024.
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.
Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of the vaccine outside of the NHS
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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...
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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