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Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 8 (PDF)

Found: The published risk and control intervals for Kawasaki disease (KD) were applied to vasculitides given

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/908 - attachment 3 (PDF)

Found: solution for injection COVID -19 Vaccine (ChAdOx1 S [recombinant]) Therapeutic area: Prevention of coronavirus

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/945 - attachment 2 (PDF)

Found: Gastrointestinal atonic and hypomotility disorders NEC Constipation 4 0 Gastrooesophageal reflux disease

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 6 (PDF)

Found: We used a negative control outcome ,i.e., COVID -19 disease in the first 14 days after time zero to

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 2 (PDF)

Found: 2 (SARS -CoV-2) causes the coronavirus disease 2019 (COVID -19) and has led to a global pandemic.

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 4 (PDF)

Found: severe acute respiratory syndrome coronavirus 2 (SARS -CoV-2) causes coronavirus disease 2019 (COVID

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 1 (PDF)

Found: Regionale di Sanità Della Toscana (Regional Health Agency of Tuscany) AZ AstraZeneca AB COVID -19 coronavirus

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 5 (PDF)

Found: vACcine Covid -19 monitoring readinESS AESI Adverse Events of Special Interest CDC Centers for Disease

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 18 December 2023
Document: FOI 23/905 - attachment 7 (PDF)

Found: Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer- BioNTech Coronavirus

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 27 November 2023
Document: FOI 23/858 - attachment (PDF)

Found: The MHRA state“Validation of any proposed analytical methods must be de monstrated as part of the control