Archive for MHRA Updates
Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22
Source: MHRA / Gov.uk 9.5.22 GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is...
Health Secretary meets with HRT suppliers to resolve supply issues
Source: Department of Health and Social Care, Maria Caulfield MP, and The Rt Hon Sajid Javid MPPublished5 May 2022 Urgent action continues to be taken to ensure women across the UK...
Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21
Source: MHRA 5.5.22 Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure MDR number MDR 009-03/22 Company name Pfizer Limited Product...
April 2022 Final Price Concessions Update
Drug Tariff News – April Part VIIIA reimbursement prices (issued 29 April) The Department of Health and Social Care has agreed the April Drug Tariff Part VIIIA reimbursement prices for...
Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20
Source: MHRA 28.4.22 Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine...
SSP019 Oestrogel® Pump-Pack 0.06% gel (PDF:167KB)
SSP019 Source: DHSC / NHSBSA SSP Total quantity supplied under this protocol to be equivalent to three months’ supply of the prescribed medicine. Click here for full details
SSP020 Ovestin® 1mg cream (PDF:166KB)
Source: DHSC / NHSBSA SSP SSP020 Total quantity supplied under this protocol to be equivalent to three months’ supply of the prescribed medicine. Click here for full details
SSP021 Premique® low dose 0.3mg/1.5mg modified-release tablets (PDF:166KB)
Source: DHSC / NHSBSA SSP SSP021 Total quantity supplied under this protocol to be equivalent to three months’ supply of the prescribed medicine. Click here for full details
Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19
Source: MHRA 27.4.22 Crescent Pharma Limited are recalling Paroxetine 40mg Film Coated Tablets as a precautionary measure. MDR number MDR 136-03/22 Company name Crescent Pharma Limited Product name Paroxetine 40mg...
Annual flu letter for 2022-2023
Source: UK Health Security Agency, NHS England, and Department of Health and Social Care 22.4.22 The annual flu letter describes the national flu immunisation programme and outlines which groups are eligible for...
Pregabalin (Lyrica): findings of safety study on risks during pregnancy
Source: MHRA 19.4.22 Advice for healthcare professionals: an observational study of more than 2,700 pregnancies exposed to pregabalin has shown use in the first trimester to be associated with a...
Consultation on a new Code of Practice for the Expert Advisory Committees
Source: MHRA & Commission on Human Medicines We are consulting on a set of proposals to improve and strengthen the Code of Practice for experts who provide advice on which...