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Please could you provide the currently approved .pdf artwork mock-up of the outer label/carton and inner label of the product Lynparza 150mg film-coated tablets, under licence number PLGB 17901/0034? I have attached the current SmPC to confirm the licence details.
Published: 9 October 2025
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I hope this message finds you well. I am writing on behalf of Coripharma ehf to kindly request any available ERA documentation concerning the product Entocort CR 3mg Capsules (PL 36633/0006), or informed consent application Budesonide CR 3 mg Capsules PL36633/0012, which was based on Entocort.
Published: 9 October 2025
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Please provide the "written evidence from relevant experts that were not able to attend the meeting" of COMMISSION ON HUMAN MEDICINES (CHM) COVID-19 VACCINES BENEFIT RISK EXPERT WORKING GROUP held on Friday 22nd July 2022 at 11:30, referred to in paragraph 7.5 in the minutes: https://www.whatdotheyknow.com/request/unredacted_minutes_from_chm_covi/response/3138668/attach/3/IR2025%2000081%20revised%20response%2028%2008%202025.rtf?cookie_passthrough=1
Published: 9 October 2025
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I am writing to request information under the Freedom of Information Act (or otherwise available regulatory channels) regarding the manufacturer of Minoxidil products marketed in the UK under the brand “Sons”. Specifically, I would like to know: - The licensed manufacturer(s) responsible for the production of Minoxidil solution sold by Sons; - The manufacturing site licence numbers and addresses associated with this product; - Any available information regarding the authorisation or approval under which Sons markets Minoxidil in the UK.
Published: 9 October 2025
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Under the freedom of information act 2000 Please could you provide me with the following: 1) All the reported suspected deaths from the covid 19 vaccines in England. All the serious adverse reactions reported in England. 2) All the reported suspected deaths from the covid 19 vaccines in Wales. All the serious adverse reactions reported in Wales. 3) All the reported suspected deaths from the covid 19 vaccines in Scotland. All the serious adverse reactions reported in Scotland. You are currently working on the information for Northern Ireland and I would appreciate the above information to compare the results to each region.
Published: 9 October 2025
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can we please request just the bio-equivalence tables for both products.
Published: 9 October 2025
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I would like to submit a FOI request for all available data pertaining to reported reactions and deaths for the chickenpox vaccination based on ethnicity for the last 20 years.
Published: 9 October 2025
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I would like to request for Module 2.4 and Module 2.5 submitted for Kwells 300 microgram tablets, MAH: Dexcel®-Pharma Ltd, (PL 14017/0299).
Published: 9 October 2025
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We do have a couple of follow up questions to clarify your statement. The first question relates to the statement: However, we do not currently consider vitamins and minerals administered intravenously or by injection to have pharmacological, immunological or metabolic action and therefore, provided that no medicinal claims are made, injectable products administered for a nonmedicinal purpose can be regarded to fall outside the definition of a medicinal product and outside the remit of the MHRA. We highlighted that, at the current time, an approved establishment WDA 49864 is able to promote and sell on their website an 8g/50ml ascorbic acid parenteral preparation as a supplement. Our product is a 7.5g/50ml ascorbic acid parenteral preparation which is licensed accordingly: PL 14369/0009. Clearly the licensed product is not inert, has active ingredients, and has pharmacological properties – hence its required licensed status, so is it therefore logical to extrapolate and assume that a bioequivalent product also has the same pharmacological properties and therefore cannot be deemed a supplement? Also, the primary intended purpose of the product and the manner in which it would be used requires consideration. By the very nature of a parenteral preparation there is associated pharmacovigilance with a relative greater risk of adverse events (including infection; extravasation; degradation of product) that may arise as a result of its design, formulation and mode of administration that surely would require oversight by the MHRA? Indeed, The Human Medicines Regulations 2012 state within https://www.legislation.gov.uk/uksi/2012/1916/schedule/1/part/1 The following medicinal products shall be available only on prescription— a product for parenteral administration Please can we have an explanation as how two products that are effectively bioequivalent can be seen as either a supplement or a licensed product respectively? The second question relates to the statement on medical claims. Could you clarify where you determine a medical claim to be made – eg for example but not limited to a manufacturer in its packaging leaflets (if it’s not supplied to a patient), an advert, a prescriber to a customer etc. This would be really useful in determining what and where a claim is in or outside of MHRA rules.
Published: 9 October 2025
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Can you please provide us with the Public Assessment Reports for the following Glycopyrronium Bromide 1mg/5ml Oral Solution licences, which were granted last year: 1. PL25258/0392 - Glenmark Pharma 2. PL15764/0164 - Strandhaven Ltd t/a Somex Pharma
Published: 9 October 2025
