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Arms Length Body Publication (Awaiting development)
NICE

Source Page: Subcutaneous efgartigmod with recombinant human hyaluronidase PH20 for treating chronic inflammatory demyelinating polyneuropathy ID6409
Document: 29647-Efgartigimod-PH20-SC-for-Chronic-Inflammatory-Demyelinating-Polyradiculoneuropathy-V1.0-DEC2023-NON-CONF.pdf (nihr.ac.uk) (PDF)

Found: It is not intended to b e a definitive statement on the safety, efficacy or effectiveness of the health

Arms Length Body Publication (Awaiting development)
NICE

Source Page: Irbesartan–propagermanium for treating focal segmental glomerulosclerosis in people 12 years and over having an angiotensin II receptor blocker TS ID 12000
Document: 26875-DMX-200-for-Focal-Segmental-Glomerulosclerosis-V1.0-JAN2024-NON-CONF.pdf (nihr.ac.uk) (PDF)

Found: It is not intended to b e a definitive statement on the safety, efficacy or effectiveness of the health

Arms Length Body Publication (In consultation)
NICE

Jul. 24 2024

Source Page: MRI-guided focused ultrasound subthalamotomy for treating Parkinson's
Publication Type: Interventional procedure consultation
Document: Supporting documentation (downloadable version) PDF 700 KB (webpage)

Found: ............... ................................ ................................ ............ 31 Safety

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

Sep. 04 2024

Source Page: CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007
Document: CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007 (PDF)

Found: Device Safety Information (DSI) CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk

Arms Length Body Publication (Awaiting development)
NICE

Source Page: MIM8 for preventing bleeding episodes in haemophilia A in people 1 year and over ID6400
Document: 29193-NNC0365-3769-for-Haemophilia-A-V1.0-DEC2023-NON-CONF.pdf (nihr.ac.uk) (PDF)

Found: It is not intended to b e a definitive statement on the safety, efficacy or effectiveness of the health

Deposited Papers

Mar. 10 2009

Source Page: Clean hands save lives: patient safety alert, second edition 2 September 2008. 4 p.
Document: DEP2009-0728.pdf (PDF)

Found: Clean hands save lives: patient safety alert, second edition 2 September 2008. 4 p.

Select Committee
Dr Nagu Penakacherla
 NHL0012 - NHS leadership, performance and patient safety

Written Evidence Apr. 24 2024

Inquiry: NHS leadership, performance and patient safety
Inquiry Status: Closed
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)

Found: NHL0012 - NHS leadership, performance and patient safety Dr Nagu Penakacherla Written Evidence

Written Question
Coronavirus: Vaccination
Wednesday 21st August 2024

Asked by: Christopher Chope (Conservative - Christchurch)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment his Department has made of the potential risk of people with partial trisomy experiencing heart complications following an mRNA vaccine; and if his Department will take steps to ensure that the decision of Mr Justice Hayden in the Court of Protection is communicated to all health service professionals.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

There has been no formal review of the potential risk of people with partial trisomy experiencing heart complications following an mRNA vaccine, although the safety of vaccines is continually monitored by the independent Medicine and Healthcare products Regulatory Agency (MHRA). The MHRA conducted detailed analysis of all Yellow Card reports of heart inflammation, specifically myocarditis and pericarditis, which occurred following an mRNA vaccine. Details of these analyses were published weekly in the MHRA’s Coronavirus Vaccine - Summary of Yellow Card Reporting, which is available at the following link:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

These analyses did not identify a specific safety concern in relation to patients with congenital conditions, such as trisomy, who received an mRNA vaccine.

In relation to the judgement of the Hon. Mr Justice Hayden, there are currently no plans to communicate the decision from this specific case to all healthcare professionals. As with all vaccines, should any information indicate a possible new safety concern, the system is well placed to rapidly and thoroughly investigate this, with advice for healthcare professionals and patients updated where appropriate.

Arms Length Body Publication (Awaiting development)
NICE

Source Page: Eplontersen for treating transthyretin-related amyloidosis cardiomyopathy TSID 12015
Document: 28555-Eplontersen-for-Familial-Amyloid-Polyneuropathy-V1.0-JUL2023-NON-CONF.pdf (nihr.ac.uk) (PDF)

Found: It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health

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

Apr. 29 2024

Source Page: Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects
Document: Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects (webpage)

Found: After a comprehensive review of the safety of finasteride, the Medicines and Healthcare products Regulatory