FOI release

Freedom of Information responses from the MHRA - week commencing 15 November 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) responses to freedom of information (FOI) requests for week commencing 15 November 2021

• From: Medicines and Healthcare products Regulatory Agency
• Published: 26 May 2022

Documents

Freedom of Information request on the documents for ‘Stelara’: Rapporteurs Day 150 Joint CHMP and PRAC Response Assessment Report (FOI 21/1104)

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Freedom of Information request updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses (FOI 21/1177)

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Freedom of Information request on temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines which were done through an expedited rolling review (FOI 21-1228)

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Freedom of Information request on the current progress of the Novavax and Valneva vaccines, which are not currently authorised for use (FOI 21/1215)

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Freedom of Information requeston the adverse drug reaction (ADR) reports the MHRA have received in association with diphtheria, tetanus, pertussis and polio (dTaP/IPV) childhood vaccine.(FOI 21/1146)

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Freedom of Information request on the Drug Analysis Print (DAP) for Prevenar 13 (FOI 21/1147)

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Freedom of Information request for a copy of the licence documents for CPAP machines and associated equipment (specifically, head straps, connector tubing, mask frames and mask cushions) (FOI 21/1172)

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Freedom of Information request on Contract Award Notice 2020 / S207-506291 - AI Software package and information system. (FOI 21/1176)

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Freedom of Information request (FOI 21-1176-1)

PDF, 117 KB, 3 pages

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Freedom of Information request on MHRA PV Inspection reports conducted between August 2019 and January 2021

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Freedom of Information request on the 486 Yellow Card adverse allergic reactions to the Pfizer vaccine, how many of these individuals had a history of allergic response to PEG, and how many had a history of a nut allergy (FOI 21/1212)

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Freedom of Information request on a list of the quantitative scientific analyses that have been conducted to date that utilise data collected in the Yellow Card database of COVID-19 vaccine adverse events.(FOI 21/1102)

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Freedom of Information request on report from: SMITHKLINE BEECHAM LIMITED INSP GMP 10592/1524-0020. ( FOI 21/1108)

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Freedom of Information request on the Novavax and Valneva vaccines, which are not currently authorised for use (FOI 21/1201)

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Freedom of Information request on timelines for the authorisation of Kaftrio in 6-11 year olds (FOI 21/1148)

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Freedom of Information request on a report from the beginning of the vaccine program in Gibraltar to the 13.10.21 (FOI 21-1224)

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Freedom of Information request on the number of adverse events reported through Yellow Card scheme for the Isle of Man that have been reported for all COVID-19 vaccines (FOI 21/1152)

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Freedom of Information request on the amount of benzyl benzoatein Testosterone Enantate 250 mg/ ml Solution for Injection (PL 16853/0116 / 0015)- (FOI 21-1206)

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Freedom of Information request on the updated figures for adverse reactions for all brands of COVID-19 vaccines to date received from the Isle of Man, and updated Drug Analysis Print attachments for each vaccine (FOI 21/1208)

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Freedom of Information request on the authorisation of Repevax ( FOI 21/1196)

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Freedom of Information request on new MAA's on Lidocaine (FOI 21/1213)

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Freedom of Information request (FOI 21-1108-1)

PDF, 399 KB, 20 pages

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Freedom of Information request (FOI 21-1104-1)

PDF, 2.75 MB, 73 pages

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Freedom of Information request (FOI 21-1146-1)

PDF, 117 KB, 2 pages

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Freedom of Information request (FOI 21-1146-2)

PDF, 58.6 KB, 33 pages

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Freedom of Information request (FOI 21-1147-1)

PDF, 68.1 KB, 35 pages

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Freedom of Information request (FOI 21-1147-2)

PDF, 117 KB, 2 pages

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Freedom of Information request (FOI 21-1152-1)

PDF, 28.4 KB, 17 pages

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Freedom of Information request (FOI 21-1152-2)

PDF, 38.2 KB, 22 pages

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Freedom of Information request (FOI 21-1152-3)

PDF, 102 KB, 27 pages

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Freedom of Information request (FOI 21-1208-1)

PDF, 117 KB, 2 pages

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Freedom of Information request (FOI 21-1208 -2)

PDF, 28.4 KB, 17 pages

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Freedom of Information request (FOI 21-1208-3)

PDF, 38.2 KB, 22 pages

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Freedom of Information request (FOI 21-1208- 4)

PDF, 102 KB, 27 pages

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Details

The Medicines and Healthcare products Regulatory Agency (MHRA) responses to freedom of information (FOI) requests for week commencing 15 November 2021

Published 26 May 2022