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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.
Summary of the latest safety advice for medicines and medical device users
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator...
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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