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Many thanks for your response and providing the numbers. However, I was hoping to have a similar response to the attached sent in August whereby we can see what was actually reported, not just numbers per month. Having the details on what was reported to cross-check and ensure we are aware of the issues raised to MHRA. Is it possible to have similar detail provided for the months requested?
Published: 22 November 2024
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Regarding FOI 22/602 https://www.whatdotheyknow.com/request/risk_management_did_mhra_request#incoming-2018600 A. With reference to MHRA's response to questions 3 and 4 - "It is a requirement for any company seeking authorisation of their medicinal product by MHRA to provide all data from clinical studies conducted/what was the response to the request (or what were the responses) from the vaccine manufacturers?" - can you: (i) provide the data submitted (ii) confirm whether MHRA assessed this data and how they went about it (eg, "A 6-person team of independent experienced industry professionals employed/contracted by MHRA assessed the data over a period of one month"), and (iii) provide MHRA's final assessment of the data. B. Can you confirm which informed consent protocols apply during the administration of EUA medicinal products? Are a differing set of protocols adhered to in such circumstances that deviate from the norm (BMA/GMC/Green Book Chapter 2, etc)?
Published: 22 November 2024
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We seek your assistance under provision of Freedom of Information for the following product: Amphotericin B SUN liposomal 50 mg powder for dispersion for infusion is first authorised on 17/04/2024 in UK. MA number is PL 14894/0784 and is granted to company named Sun Pharma UK Ltd. Though it was registered in April 2024, Public assessment report for the same is still not available on MHRA website. Can you please provide the PAR for our reference.
Published: 22 November 2024
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Please can you let me know how many people reported adverse reactions to my batches of the AZ vaccine and how many associated deaths. Dose 1 AB0008 Dose 2 PW40009
Published: 22 November 2024
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We have been made aware of 2 severe allergic reactions to generic tazocin in our emergency department over the weekend. We believe at least one of them to be a true anaphylaxis reaction and has since passed away. Both patients were not listed as allergic to pencillins, having received penicillins in the past and the 2nd patient had previously received courses of tazocin in the past (as recently as September 2024) without issue. Our medical colleagues will be producing yellow card reports in due course, but I wanted to contact you to see if there have been any increased reports relating to tazocin? And also any in particular to the generic brand Antibiotice?
Published: 22 November 2024
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Under the Freedom of Information Act 2000, I would like to request information regarding MHRA GPvP Inspection report for DAWA Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, MAH Company number - PL 30684
Published: 22 November 2024
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Under the Freedom of Information Act 2000, I would like to request information regarding MHRA GPvP Inspection report for STRANDHAVEN LIMITED, 600 High Road, Seven Kings, Ilford, Essex, IG3 8BS MAH company number - PL 15764.
Published: 22 November 2024
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I would like to request to receive the number of reported cases of meibomian gland dysfunction (MGD), blepharitis or dry eyes from being on roaccutane/isotretinoin medication? Or any Opthalmic problem from being on roaccutane medication? It seems to be very common and reported all over social media and over the internet. Many Opthalmologists have patients who have severe cases from being on roaccutane medication but this is not showing as a severe alert/warning. Every opthamologist that I have seen has some patients with severe problems as a result. On the side effect leaflet it shows as dry eyes being a common side effect whilst you’re on medication but then dermatologists will tell you that it will go back to normal when you come off the medication, but there are so many cases where it doesn’t and living with severe dry eyes/MGD can destroy your life. Many patients with chronic problems, class there dry eyes as being the worst condition they have and it was classified as being similar to angina in terms of pain. Most treatments aren’t very effective at relieving discomfort. It can prevent people from living a normal life and leaves people with having suicidal ideations. Some people who have corneal neuralgia on own or in combination with severe dry eyes have committed suicide. It’s only showing up as a serious alert for pregnancy whilst being on the medication and mental health difficulties, where there have been some procedures in place to try to reduce these risks whilst on the medication. People should be given a leaflet about dry eyes, they should get them to have their eyes checked to ensure they don’t have any dry eyes prior to starting the treatment and be informed at the consultation that it could lead to permanent changes with there eyes. They should be advised to use supplements and drops during the course of their treatment if they do decide to proceed.
Published: 22 November 2024
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1. Semaglutide Prescriptions by Online Pharmacies or aesthetic (non-GP) clinics: * The total number of semaglutide prescriptions dispensed by online pharmacies and by aesthetic clinics in the United Kingdom over the past 12 months. * A monthly breakdown of these prescriptions, if available. 1. GP Cancellations Due to BMI Requirements: * The number of semaglutide prescriptions cancelled or not issued by General Practitioners (GPs) because patients did not meet the Body Mass Index (BMI) criteria as specified by the National Institute for Health and Care Excellence (NICE) guidelines. I am attempting to understand what, if any side-effects are being experienced by this group, so am keen to understand the size of the population form which I can draw my sample. Please let me know if there is any cost associated with fulfilling this request or if you require further clarification.
Published: 22 November 2024
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On 8 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published a press release confirming that MHRA has approved elafibranor (Iqirvo) to treat adult patients with primary biliary cholangitis. I write to request access to the following information under Section 1(1) of the Freedom of Information Act 2000 (FOIA): 1. Please confirm whether elafibranor (Iqirvo) has been granted a conditional marketing authorisation (CMA) or a standard (full) marketing authorisation (MA). * In case it is a conditional approval, please provide the conditions associated with the MA. * In case it is full MA, please provide the scientific rationale, given that the EMA and US FDA has granted a CMA/ accelerated approval recently. * Please also provide details of any post-approval commitments that forms basis of the approval. 1. Please provide (i) the original version (as submitted by the applicant);and (ii) the final version (at the time of approval), of the clinical overview (Module 2.5) of the marketing authorisation application of elafibranor (Iqirvo). 1. Please provide correspondence (including questions and answers) exchanged between the applicant and MHRA including the final scientific assessment report related to the assessment of clinical benefit of elafibranor (Iqirvo). 1. Please confirm the current status of orphan designation of elafibranor (Iqirvo) in UK following the issuance of PLGB license, and provide the supporting data submitted by the applicant to support the orphan designation. Please respond within 20 working days pursuant to Section 10(1) FOIA. If you have any queries regarding this request (or require payment for complying with this request), please contact us as soon as possible.
Published: 22 November 2024
