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List of Field Safety Notices (FSNs) from 21 to 25 November 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (…
List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020.
People who have purchased Clear & Simple Digital Pregnancy Tests are advised to check the lot number after some tests have returned inaccurate results.
MHRA has today published its first blog.
People who may have purchased Yiganerjing Cream are urged to discontinue use immediately as it contains an undisclosed steroid and two antifungal ingredients.
TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia.
New monitoring instructions to detect these side effects as soon as possible.
Guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products.
List of Field Safety Notices from 29 January to 2 February 2024.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines
List of Field Safety Notices from 5 to 9 February 2024.
The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new a…
Anastrozole is now authorised as a preventative treatment for post-menopausal women at moderate or high risk of breast cancer.
New Years warning issued urging athletes to avoid potentially dangerous DMAA, otherwise known as Methylhexanamine
List of sites granted a manufacturer or wholesale dealer licence
G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 2017.
A similar biological medicinal product (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (“reference” product).
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