List of Field Safety Notices from 22 to 26 September 2025.
Similar Posts
Isotretinoin: an expert review of suspected psychiatric and sexual side effects
The review of the safety of isotretinoin has concluded.
Research: Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
Guidance: Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
MHRA approves adrenaline nasal spray – the first needle-free emergency treatment for anaphylaxis in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 18 July 2025, approved adrenaline (epinephrine) nasal spray (EURneffy) to be used for the emergency treatment of serious allergic reactions, known as anaphylaxis.
Electronic Common Technical Document (eCTD) submissions update
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks in patients aged 12 and over
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 July 2025, approved sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.