GovWire

These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.

Public Assessment Report of review of Topiramate safety data and expert advice on management of risks.

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.

List of Field Safety Notices from 3 to 7 June 2024.

Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to date safety information.

MHRA performance metrics for clinical trials and established medicines assessment.

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

List of Field Safety Notices from 27 to 31 May 2024.

Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.

Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

Marketing authorisations granted in 2024

Parallel import licences granted in 2024

Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).

List of Field Safety Notices from 27 to 31 May 2024.

Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.

Department of Health and Social Care and MHRA register of electronic export certificates (human).

Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table.

Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.

A list of authorised orphan medicinal products registered by the UK licensing authority.

List of Field Safety Notices from 20 to 24 May 2024.

Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.

Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months, as a result of regulatory action, topical steroid products will be labelled with information on their potency to simplify advice for patients.

A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert highlighting the need for reducing risks for transfusion associated circulatory overload (TACO).

A list of centrally authorised product (CAP) bridging mechanism products registered by the UK Licensing Authority.