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I am writing to request further Information on the AstraZeneca COVID-19 vaccine batches PV46672 and PV46697. Specifically, I would like to request: 1. The total number of doses from each batch (PV46672 and PV46697) that were distributed and administered in the UK. 2. The total number of Yellow Card reports received for each batch, broken down by: 3. Serious vs. non-serious suspected reactions 4. Fatal vs. non-fatal suspected reactions 5. Type/category of suspected reaction (if available, e.g. cardiovascular, neurological, clotting, etc.) 6. 7. The time range over which these reports were received. 8. Any MHRA safety assessments or investigations that have specifically considered these two batches. I understand that batch numbers are recorded inconsistently, but would be grateful for any data that you can provide.
Published: 5 November 2025
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I am writing under the Freedom of Information Act 2000 to request information regarding the product Butamirate Syrup, reportedly associated with the following marketing authorisation number: * Product: Butamirate Syrup 7.5mg/5ml * PL Number: 30306/0497 * MA Holder: Actavis Group PTC ehf I kindly request confirmation of whether this product currently holds (or previously held) a valid UK Marketing Authorisation (MA). If available, I would appreciate a copy of the MHRA-issued approval certificate or public details related to the licensing status, including any dates of authorisation, renewal, withdrawal, or cancellation.
Published: 5 November 2025
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We are currently working on an ERA for the active substance Baclofen to be submitted in a procedure for a medicinal product indicated for multiple sclerosis, spinal lesions, (e.g. tumours of the spinal cord), syringomyelia, motor neurone disease, transverse myelitis, and traumatic partial section of the cord. In accordance with Article 7 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents and in view of the EMA updated Guideline on the environmental risk assessment of medicinal products (EMEA/CHMP/SWP/4447/00 Rev. 1-Corr), we would like to request for all document 1.6 Environmental Risk Assessment reports submitted for the medicinal product Lioresal(r) Tablets & Liquids. This request is made with the intention of avoiding unnecessary duplication of environmental studies/environmental exposures, in accordance with the principles of animal welfare under the provision of FOI.
Published: 5 November 2025
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I am submitting this Freedom of Information (FOI) request to seek updates on safety assessments of the SV40 promoter in mRNA vaccines, particularly related to the Pfizer/BioNTech COVID-19 vaccine. I refer to previous FOI responses, specifically FOI 24/212, which confirmed that the SV40 promoter is inactive and within safety limits (<10 ng/dose), and FOI 24/115, which provided pharmacovigilance inspection reports for the period 1 December 2022 to 1 February 2024. I also note the study by Igyártó and Qin (2024), which supports the safety of SV40 promoter residuals in. In light of your advice, I am refining my original request to make it more specific and manageable while continuing to address the significant public interest in transparency regarding the safety of mRNA vaccines, particularly concerning the SV40 promoter and its potential health impacts. Below is the refined request: Safety Assessments and Reports Related to SV40 Promoter in Comirnaty: The MHRA assessment report and documentation submitted with the variation (PLGB 53632/0002-0273) related to the sequence elements in the plasmid DNA used in the Comirnaty drug substance manufacturing, as referenced in your response. Any additional safety assessments, reports, or documents produced or received by the MHRA since FOI 24/212 (up to 16 August 2025) that specifically address the presence of the SV40 promoter in DNA residuals of the Comirnaty vaccine, with a focus on potential health impacts such as cancer risk or gene expression. If no such documents exist, please confirm this. Monitoring and Testing Protocols for DNA Residuals: Documents outlining the monitoring and testing protocols (e.g., using qPCR or similar methods) for DNA residuals, specifically the SV40 promoter, in the Comirnaty vaccine, covering the period from 1 January 2024 to 16 August 2025. If these protocols are part of the documentation for the variation (PLGB 53632/0002-0273), please include them or indicate where they can be found. Update on Pharmacovigilance Inspection Report (FOI 24/115): Confirmation of the current status of the pending pharmacovigilance inspection report withheld under FOIA Section 30 in FOI 24/115. If the report is still unavailable, please provide an estimated timeline for its release. I understand that some information may be subject to exemptions under FOIA, such as Section 40 (personal data) or Section 43 (commercial interests). However, I kindly request the fullest possible disclosure, as public concerns about the SV40 promoter and its perceived risks are significant for maintaining trust in vaccine safety. If any information cannot be released, please provide specific reasons and, where applicable, an estimated timeline for availability.
Published: 5 November 2025
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Can you please let me know in the UK is gabapentin licensed for usage in fibromyalgia, in reference to the Cochrane review below I appreciate it is in 2017 hence wondered if there was any updates Is there any new evidence or trials as the blow Cochrane review suggests very low quality evidence and it is very uncertain about estimates of benefit and harm because of a small amount of data from a single trial I would be grateful for your expert advice and opinion
Published: 5 November 2025
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Under the Freedom of Information Act, please could you provide the current approved Paediatric Investigation Plan (PIP) MHRA-100443-PIP01-22 for BARICITINIB?
Published: 5 November 2025
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Please provide any Yellow Card data that specifically relate to over-the-counter codeine dependence, broken down by product and by year from 2015 to the present (summary totals only, not individual case reports). In Google Sheets/excel if possible. If the request risks exceeding the cost limit, please prioritise the most recent five years.
Published: 5 November 2025
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Hi team have a query regarding Multicompartment compliance aids/ dosette boxes/ monitored dosage systems etc. Can you do a search via yellow card to see if other incidents involving medication in these aids/devices are reported? or is there a facility to purposely log incidents involving these aids/devices and medication?
Published: 5 November 2025
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Please could you provide me with copies of the MHRA assessment report(s) of orphan drug status and new active substance status for the product Nexviadyme (PLGB 04425/0893).
Published: 5 November 2025
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I would be grateful if you could provide teh RMPs as suggested in your letter i.e. brand leader Topamax (PL 00242/0303) instead of Topiramate, and Revlimid (PLGB 15105/0116-0122) instead of Lenalidomide Tablets.
Published: 5 November 2025
