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Dear Sir/Ma'am, Zydus Lifesciences requests MHRA to provide below information for our reference purpose: 1. Quality assessment report 2. Non-Clinical and Clinical Overview for below product 3. Major objection letters and corresponding responses 4. Device assessment and human factors/usability assessment FOR Product Name: SUGAMMADEX 10 mg/ml solution for injection in pre-filled syringe. MAH: LABORATOIRE AGUETTANT MA No: PL 14434/0059
Published: 14 September 2026
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We have come across information indicating that Sucralfate Oral Suspension manufactured by Roma has been approved by the MHRA. In this regard, we would like to kindly request, if available, the following documents for reference purposes only: Public Assessment Report (PAR) Clinical Overview/Summary Non-Clinical Overview/Summary
Published: 14 September 2026
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Dear Sir/Ma'am, Zydus Lifesciences requests MHRA to provide below information for our reference purpose: 1. Quality assessment report 2. Non-Clinical and Clinical Overview for below product 3. Major objection letters and corresponding responses 4. Device assessment and human factors/usability assessment 5. UK PAR FOR Product Name: Sugammadex 100 mg/ml solution for injection in pre-filled syringe MAH: Accord Healthcare Limited MA No: PL 20075/1511
Published: 14 September 2026
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I would like to request for Module 2.4, Module 2.5 and Module 2.7 submitted for Cyanocobalamin 50 microgram Film-coated Tablets, MAH: Dawa Ltd, (PL 30684/0243).
Published: 14 September 2026
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I would like to request for Module 2.4, Module 2.5 and Module 2.7 submitted for Cyanocobalamin 50 microgram Film-coated Tablets, MAH: Glenmark Pharmaceuticals Europe Ltd, (PL 25258/0369).
Published: 14 September 2026
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Re: Request for Mexiletine Clinical Overview and Risk Management Plan I would be grateful if you could provide a copy of the Clinical Overview and the Risk Management Plan for the authorised products: * Mexiletine Hydrochloride 100 mg Hard Capsules * Mexiletine Hydrochloride 200 mg Hard Capsules * PL 06464/3133–3134 * MAH: Waymade PLC
Published: 14 September 2026
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I am making a request under the Freedom of Information Act 2000 concerning adverse incident reports involving Nevro spinal cord stimulation systems in the United Kingdom. Please provide information held by the MHRA for the period 1 January 2020 to the date of this request concerning medical-device adverse incident reports relating to: • Nevro HFX • Nevro Senza • Senza II • Senza Omnia / Omnia • Nevro implantable pulse generators (IPGs), particularly model NIPG2500 I would specifically like to know: 1. The total number of UK adverse incident reports received concerning these devices, broken down by calendar year where possible. 2. Where recorded, the number of reports involving any of the following: • electric shock or electric-shock-like sensations • unintended or abnormal stimulation • overstimulation • muscle spasms, contractions or involuntary movements • burning sensations • heating or abnormal warmth around the implanted IPG • pain at or around the IPG/battery pocket • pain along the lead or IPG-to-lead pathway • battery or IPG malfunction • charging problems • abnormal electrode/contact impedance • lead or connector malfunction • device or IPG migration 1. Where recorded, the number of incidents in which symptoms were reported to stop, substantially improve or otherwise change when stimulation was switched OFF. 2. The number of reported incidents resulting in: • revision surgery • replacement of the IPG/generator • replacement of leads • complete explantation of the spinal cord stimulation system • serious injury • death 1. Specifically for the Nevro NIPG2500, please provide the number of adverse incident reports involving this model and, where possible, the reported event/problem categories and outcomes. 2. Where disclosure is permitted, please provide anonymised incident narratives or summaries for reports involving electric-shock sensations, abnormal stimulation, muscle spasms/contractions, burning/heating or pain associated with the IPG. I am not requesting any patient-identifiable information. If providing individual incident narratives would engage an exemption or cause this request to exceed the appropriate cost limit, please provide the requested numerical/aggregated information and event categories instead. If any part of this request is considered too broad to process within the statutory cost limit, I would be grateful if you could provide advice and assistance under Section 16 of the Freedom of Information Act as to how I might narrow the request while retaining information specifically concerning NIPG2500/HFX adverse incidents. I would prefer the information electronically, ideally in spreadsheet or CSV format if the data are held in a structured database.
Published: 14 September 2026
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Under the Freedom of Information Act 2000, please provide the following information concerning energy powders marketed for nasal use, including products described as "energy sniff", "snortable caffeine" or "nasal energy powder", and the brands Wildkraut, BUMPZ, KoffKAIN and WP Energy. For the period from 1 January 2023 to 27 July 2026, please provide: 1. The number of complaints, safety reports, referrals or enquiries received concerning these products. 2. A breakdown by product or brand, where recorded. 3. The number referred to the MHRA's Borderline Products team or otherwise assessed to determine whether they constituted medicinal products. 4. The outcome of any such assessments. 5. Copies of any safety alerts, risk assessments or correspondence with the Food Standards Agency or Trading Standards concerning these products, subject to appropriate redaction. If no information is held for the named brands, please confirm whether the MHRA holds any information concerning the broader categories "nasal energy powder", "snortable caffeine" or "energy sniff".
Published: 14 September 2026
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We have interest in receiving all of the user consultation reports, i.e. for all the MAs: PL 40546/0178-0179, PL 00427/5014R, PL 00427/0054 and PL 58839/0070-0071.
Published: 14 September 2026
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I am writing to request information under the Freedom of Information Act 2000 regarding the AstraZeneca COVID-19 vaccine, specifically batch number PV46662. This request is intended as an update to the information previously provided in FOI 22/713, which contained data up to 25 May 2022. I would be grateful if you could provide the same information using the most recent data available at the date this request is processed. Specifically, I request the following: 1. Total Adverse Reaction Reports * The total number of UK Yellow Card reports received for AstraZeneca COVID-19 vaccine batch PV46662 from the beginning of reporting to the most recent date available. 1. Breakdown of Adverse Reactions * An updated Vaccine Analysis Print (VAP) or equivalent document showing all reported suspected adverse reactions associated with batch PV46662. * Any accompanying guidance notes required to interpret the data. 1. Patient Ethnicity * An updated breakdown of adverse reaction reports by reported patient ethnicity, in the same format as provided in FOI 22/713. 1. Comparison with Other AstraZeneca Vaccine Batches * Please provide any analysis held by the MHRA comparing batch PV46662 with other AstraZeneca COVID-19 vaccine batches, including: * The total number of Yellow Card reports received for each batch (or the batches with the highest numbers of reports, if providing every batch would exceed the appropriate cost limit). * Any analysis comparing reporting rates between batches where the number of doses administered is known. * Whether batch PV46662 has been identified as having a higher, lower or expected rate of suspected adverse reaction reports compared with other AstraZeneca vaccine batches. * Details of any internal reviews, investigations, signal assessments or pharmacovigilance analyses undertaken specifically in relation to batch PV46662. * Whether PV46662 has ever been the subject of any batch-specific safety signal, investigation or enhanced monitoring, and if so, please provide details and the outcome of that assessment. 1. Ocular (Eye-Related) Adverse Reactions * Please provide details of all reported ocular or ophthalmic adverse reactions associated with batch PV46662, including: * The reported ocular adverse reaction terms (using MedDRA preferred terms where available). * The number of reports for each ocular adverse reaction. * The number of serious and non-serious reports for each ocular adverse reaction, where recorded. * Any MHRA signal assessments, reviews or conclusions specifically relating to ocular adverse reactions associated with this batch. 1. Fatal Outcomes * The number of Yellow Card reports associated with batch PV46662 that reported a fatal outcome, noting that a reported fatality does not imply causation. 1. Serious Adverse Reactions * The number of reports classified as serious, together with a breakdown of the seriousness criteria where available (e.g. hospitalisation, life-threatening event, disability, congenital anomaly, medically significant event or death). 1. Batch Distribution Information * If held by the MHRA, please provide: * The total number of doses from batch PV46662 supplied or administered within the UK. * If this information is not held by the MHRA, I would be grateful if you could confirm this and advise whether it is held by the UK Health Security Agency (UKHSA) or another public authority. 1. Regulatory Assessment * Please confirm whether the MHRA's current assessment remains that no batch-specific safety concerns have been identified for PV46662, or whether this assessment has changed since the response provided under FOI 22/713. * If the assessment has changed, please provide details of the evidence supporting that change. Where information is exempt from disclosure, I would be grateful if you could cite the specific exemption(s) relied upon and release any remaining information that is not exempt. Where possible, I request that the information be provided electronically in PDF or spreadsheet format. If any part of this request is likely to exceed the appropriate cost limit under the Freedom of Information Act, please advise me how the request may be refined so that the information can be provided.
Published: 14 September 2026
