Summary of the latest safety advice for medicines and medical device users
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Guidance: MORE Registrations – user reference guide
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
Field Safety Notices: 25 to 29 August 2025
List of Field Safety Notices from 25 to 29 August 2025.
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Quetiapine Oral Suspension (unlicensed medicine), manufactured by Eaststone Limited due to a potential for overdosing, NatPSA/2026/002/MHRA
Eaststone Limited is initiating a recall of all batches of quetiapine oral suspension products due to a potential risk of overdose, which could have consequences for the safety of patients.