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I am looking to submit a freedom of information request regarding the MHRA yellowcard scheme. Specifically, I am looking to determine: (1) The number of adverse events reported for any class of GLP-1 inhibitor injection (Mounjaro, Trulicity, Victoza, Ozempic and Wegovy) from January 1st 2023, to December 31st 2024, broken down by primary complaint/issue/reason for reporting, and… (2) The number of adverse events for any of the above medicines which were reported by the marketing authorisation holder specifically, as opposed to a member of the public or healthcare professional, over the same period of time (January 1st 2023 to December 31st 2024).
Published: 25 April 2025
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We would like to request the following documents related to XGEVA 120 mg solution for injection in pre-filled syringe (PLGB 13832/0091) approved by MHRA under the International Recognition Procedure. 1) Assessment report of reference regulator EMA for this product under the procedure number EMEA/H/C/002173/II/0082/G. 2) Clinical study report [including all its appendix(ces)] of clinical study conducted by the Sponsor/Applicant to support assessment and approval of XGEVA 120 mg/mL solution for injection in pre-filled syringe.
Published: 25 April 2025
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This is a freedom of information request for you to provide copies of the following: all correspondence within the Medical and Healthcare products Regulatory Agency (MHRA); all correspondence between the MHRA and the Advertising Standards Authority; all correspondence between the MHRA and Lyma Life Ltd; and any documents, in each instance in relation to Lyma Life Ltd's products, the Lyma Laser and Lyma Laser Pro.
Published: 25 April 2025
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I am updating some of my training material and wondering who best to contact for figures of any device that has caused adverse events in the last year
Published: 25 April 2025
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Request for Information. Product Name: 1. Trientine 250mg Caps 2. Trientine 200mg Caps 3. Trientine 300mg Caps 4. Trientine 500mg Caps 5. Acetazolamide Prolonged Release Caps 250mg & 500mg 6. Probenecid Tabs 500mg 7. Lorazepam Injection 4mg/ml & 2mg/ml We are planning to launch above mentioned product in UK market. We understand that for some of these products MAs are not approved in UK and are imported on named patient basis. Others are approved but limited consumption. We hereby request you to kindly share below information 1. SKU and Volume ( packs) consumed in UK market in last three years 2. Number of import notification along with supplier name and volume ( packs) in last three years This information will help us to evaluate it this would be commercially viable to launch a licensed product.
Published: 25 April 2025
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Product Name: Probenecid 500mg Tablets We are in the process of planning the introduction of the aforementioned product into the UK market. We are aware that Marketing Authorizations (MAs) are currently not approved in the UK. Consequently, products are currently being imported on a named patient basis. We kindly request the following information to aid in our evaluation: 1. The volume ( in packs) imported in UK market in last three years. or/and 2. The Number of notifications approved for importing the product in last three years. If feasible, we would appreciate receiving quarterly data for the past three years, including the names of suppliers who provided the product. We understand that you may not have all of the requested information available. Therefore, we kindly ask that you share any relevant data that you do possess. This information will assist us in determining the commercial viability of launching a Licensed product in the UK.
Published: 25 April 2025
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I would like to make the following request for information under the Freedom of Information Act. This is with regard to the document published by the Commission on Human Medicines, titled "Commission on Human Medicines report on proposed permanent order to restrict the sale and supply of GnRH agonists in children and young people under 18 years of age for the purpose of puberty suppression in gender incongruence and/or gender dysphoria." URL: https://www.gov.uk/government/publications/chms-report-on-proposed-changes-to-the-availability-of-puberty-blockers/commission-on-human-medicines-report-on-proposed-permanent-order-to-restrict-the-sale-and-supply-of-gnrh-agonists-in-children-and-young-people-under-1#appendix-3-membership-of-chm Please supply me with copies of all documents, minutes of meetings, emails, memos, discussion documents, etc related to the above, which refer to the principles of selection or selection criteria, for the material named in the two references section. I want to see all documents that show the principles that guided the selection of these references and exclusion of others, which show how these were chosen to be included in this report.
Published: 25 April 2025
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We understand that the first UK reports of a CVST following vaccination using the AstraZeneca vaccine were received by the MHRA on the 3, 11 and 18 of February 2021. Please confirm on what date the MHRA received the first report and/or was first notified of a cerebral venous sinus thrombosis “CVST” following vaccination using the AstraZeneca vaccine. Please provide all related correspondence in regard to this report, and any additional reports during February 2021.
Published: 25 April 2025
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Thank you for sending the information across. However, there are only reports for London NorthWest University Healthcare and Royal Free London (these are North Central London). Within NW London we have the following trusts: * Imperial * Chelsea & Westminster Hospital * Northwick Park Hospital Please could you confirm whether you have received any yellow card reporting from these trusts?
Published: 25 April 2025
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This is a follow up request to my previous freedom of information request (ref: FOI2024/0008) concerning your review into the supply of Estra 25mg and 50mg pellets and testo-100 pellets in the UK. In your response to my previous request you confirmed that: "Considering this may be the only suitable treatment option for some patients and the absence of significant safety signals so far, the MHRA has decided to allow supply to resume following a preliminary analysis of available evidence, and while our more in-depth review continues". However, I am informed by the importer (Smartway Pharmaceuticals Ltd) that they have again been instructed to stop supplying these pellets. Please could you provide the following information concerning this decision: 1. When was the current halt on supply of the implants instituted? 2. Is this now a permanent cessation of supply? 3. If the MHRA review of these pellets has now been concluded please confirm its conclusions and provide a copy of any written report outlining these. 4. If the review is still undergoing: (i) why has the importer been instructed to halt supply now? (ii) are there any concerns for patient safety? (iii) when is it expected to conclude? 5. What consultation has been undertaken with prescribers responsible for patients currently reliant on these implants both concerning the review generally, and more specifically concerning the current half of supply. 6. Please provide copies of any communications provided to, or received from, such prescribers by MHRA. 7. Please provide copies of any communication with the US Food and Drug Administration with whom you were engaging concerning the manufacturer of the pellets.
Published: 25 April 2025
