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Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.
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.
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.
Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products. Class 2 medicines recalls were issued for batches of irbesartan/hydrochlorothiazide and irbesartan tablets.
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance for industry and organisations to follow from 1 January 2021.
List of Field Safety Notices from15 to 19 April 2024.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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