tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency Medicines and Healthcare products Regulatory Agency - Activity on ÒÁÈËÖ±²¥ HM Government 2025-04-25T13:47:46Z /government/publications/marketing-authorisations-granted-in-2025#2025-04-25T13:47:46Z 2025-04-25T13:47:46Z Decision: Marketing authorisations granted in 2025 Marketing authorisations granted in 2025. /government/publications/parallel-import-licences-granted-in-2025#2025-04-25T13:46:55Z 2025-04-25T13:46:55Z Decision: Parallel import licences granted in 2025 Parallel import licences granted in 2025. /government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic#2025-04-25T13:36:41Z 2025-04-25T13:36:41Z Decision: Medical devices given exceptional use authorisations during the COVID-19 pandemic List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. /government/news/acoramidis-approved-to-treat-wild-type-or-variant-transthyretin-amyloidosis-in-adults-with-cardiomyopathy#2025-04-25T10:54:57Z 2025-04-25T10:54:57Z Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy As with all products, the MHRA will keep its safety under close review. /government/publications/medical-devices-uk-approved-bodies#2025-04-25T08:50:10Z 2025-04-25T08:50:10Z Guidance: Medical devices: list of UK approved bodies Details of the organisations that are currently approved to undertake conformity assessments on medical devices. /drug-device-alerts/field-safety-notices-14-to-18-april-2025#2025-04-25T08:35:42Z 2025-04-25T08:35:42Z Field Safety Notices: 14 to 18 April 2025 List of Field Safety Notices from 14 to 18 April 2025. /government/news/obecabtagene-autoleucel-conditionally-approved-to-treat-adults-with-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukaemia#2025-04-24T23:00:00Z 2025-04-24T23:00:00Z Obecabtagene autoleucel conditionally approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia As with all products, the MHRA will keep its safety under close review. /drug-safety-update/short-acting-beta-2-agonists-saba-salbutamol-and-terbutaline-reminder-of-the-risks-from-overuse-in-asthma-and-to-be-aware-of-changes-in-the-saba-prescribing-guidelines#2025-04-24T11:02:48Z 2025-04-24T11:02:48Z Short-acting beta 2 agonists (SABA) (salbutamol and terbutaline): reminder of the risks from overuse in asthma and to be aware of changes in the SABA prescribing guidelines Healthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. Healthcare professionals should be aware of the change in guidance that no longer recommends prescribing SABA without an inhaled corticosteroid. /government/news/patients-with-asthma-reminded-of-the-increased-risk-of-severe-asthma-attacks-from-overusing-blue-inhalers#2025-04-24T11:02:22Z 2025-04-24T11:02:22Z Patients with asthma reminded of the increased risk of severe asthma attacks from overusing blue inhalers The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding patients with asthma of the importance of using their preventer (anti-inflammatory) inhaler regularly as prescribed, and to avoid relying on their blue inhaler alone. This is because without regular use of a preventer inhaler, symptoms could worsen and increase the risk of severe asthma attacks. /drug-device-alerts/class-4-medicines-defect-notification-brilique-90mg-tablets-el-25-a-slash-18#2025-04-24T10:01:57Z 2025-04-24T10:01:57Z Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18 G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The spelling should be ‘Ticagrelor’ but has been printed as ‘Tricagelor’ under the brand name and in the content statement. /government/news/mhra-approves-first-uk-treatment-for-friedreichs-ataxia-omaveloxolone#2025-04-23T15:26:45Z 2025-04-23T15:26:45Z MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone As with all products, we will keep its safety under close review. /government/news/marstacimab-approved-to-treat-patients-aged-12-years-and-above-weighing-at-least-35-kg-with-haemophilia-a-or-b#2025-04-22T10:09:20Z 2025-04-22T10:09:20Z Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B As with all products, the MHRA will keep its safety under close review. /government/news/patients-urged-to-check-packs-of-blood-pressure-medicine-lercanidipine-after-labelling-error#2025-04-17T13:22:11Z 2025-04-17T13:22:11Z Patients urged to check packs of blood pressure medicine lercanidipine after labelling error Patients who take the common blood pressure medicine Lercanidipine HCI 20mg tablets (lercanidipine hydrochloride) from the manufacturer Recordati Pharmaceuticals Limited, should, as a precautionary measure, urgently check if they have the batch number MD4L07 with an expiry date of 01/2028 on any packs they have at home. The batch number is printed on the foil of the blister strips. /government/news/professor-claire-stewart-appointed-to-the-commission-on-human-medicines-as-three-members-reappointed#2025-04-17T13:12:39Z 2025-04-17T13:12:39Z Professor Claire Stewart appointed to the Commission on Human Medicines as three members reappointed The appointment will involve a time commitment of 22 days per year. Remuneration for the role will be at a rate of £325 per attendance and preparation for meetings. /drug-device-alerts/class-2-medicines-recall-lercanidipine-hcl-20mg-tablets-recordati-industria-el-25-a-slash-17#2025-04-17T12:46:18Z 2025-04-17T12:46:18Z Class 2 Medicines Recall: Lercanidipine HCl 20mg Tablets, Recordati Industria, EL(25)A/17 Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Tablets. The packs are incorrectly labelled as 10mg on some sides of the product carton when they are 20mg tablets. /government/publications/mhra-performance-data#2025-04-16T13:00:06Z 2025-04-16T13:00:06Z Transparency data: MHRA Performance Data Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function. /government/publications/risk-minimisation-measures-for-medicines#2025-04-16T10:17:56Z 2025-04-16T10:17:56Z Guidance: Risk minimisation measures for medicines Guidance for healthcare professionals on risk minimisation options for medicines. /government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk#2025-04-15T15:54:51Z 2025-04-15T15:54:51Z Guidance: Medicines that you cannot export from the UK or hoard Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients. /drug-device-alerts/field-safety-notices-7-to-11-april-2025#2025-04-15T13:38:51Z 2025-04-15T13:38:51Z Field Safety Notices: 7 to 11 April 2025 List of Field Safety Notices from 7 to 11 April 2025 /government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines#2025-04-14T11:04:38Z 2025-04-14T11:04:38Z 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.