Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

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2,321 disclosures

  1. Function of excipients in Alimemazine Tartrate 7.5 mg/5 ml Syrup

    Dear MHRA, I am reviewing the Summary of Product Characteristics (SmPC) for Alimemazine Tartrate 7.5 mg/5 ml Syrup (PL 17780/0465), for which Zentiva Pharma UK Limited is the Marketing Authorisation Holder. I note that sodium sulphite anhydrous (E221) and sodium metabisulphite (E223) are included under the section “Excipients with known effect”, while L(+) ascorbic acid is listed in the full list of excipients in Section 6.1. Could you please confirm the function/role of the following excipients in this medicinal product: Sodium sulphite anhydrous (E221) Sodium metabisulphite (E223) L(+) ascorbic acid

    Published: 15 September 2026

  2. Need Generic product related information

    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

  3. PAR for Sucralfate Oral Suspension manufactured by Roma

    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

  4. Need Generic product related information

    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

  5. Cyanocobalamin 50 microgram Film-coated Tablets, MAH: Dawa Ltd

    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

  6. MAH: Glenmark Pharmaceuticals Europe Ltd

    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

  7. Request a copy of the clinical overview Mexiletine capsules

    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

  8. Freedom of Information Request – Nevro HFX/Senza Spinal Cord Stimulator Adverse Incidents

    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

  9. FOI request: Nasal energy powders

    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

  10. User consultation reports

    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