Results for all evidence | European Medicines Agency - EMA 1 - 50 of 3229 sorted by relevance / date

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Introducing criteria-led discharge in an acute medical unit

Remove: NHS Improvement source - 17 January 2020 - Publisher: NHS Improvement

A case study detailing how criteria-led discharge (CLD) was introduced on an acute medical unit at Tameside General Hospital resulting in increased weekend discharge rates.

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PRAC confirms four-week limit for use of high-strength estradiol creams (100 micrograms/gram [0.01%])

Remove: European Medicines Agency - EMA source - 17 January 2020 - Publisher: European Medicines Agency

Following a re-examination procedure, the PRAC has confirmed its recommendation to minimise risk of side effects from absorption of high-strength estradiol creams into bloodstream, following...

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European Medicines Agency (EMA) suspends Picato (ingenol mebutate) gel as a precaution while review of skin cancer risk continues

Remove: European Medicines Agency - EMA source - 17 January 2020 - Publisher: European Medicines Agency

Final results from a study comparing Picato with imiquimod indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod. EMA’s safety committee (PRAC) is...

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NHS foundation trust annual reporting manual (FT ARM)

Remove: NHS Improvement source - 10 January 2020

Guidance for NHS foundation trusts on producing their annual reports and accounts.

More: Guidance
Demand and capacity core model

Remove: NHS Improvement source - 09 January 2020

This model will help you to understand the demand and capacity needs of services with a simple pathway.

More: Implementation Support
Human medicines: highlights of 2019

Remove: European Medicines Agency - EMA source - 09 January 2020 - Publisher: European Medicines Agency

The European Medicines Agency has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. Of 66 approvals in 2019, 30 were for...

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Whistleblowers' support scheme

Remove: NHS Improvement source - 08 January 2020

This scheme helps current and former NHS workers who are having difficulty finding suitable employment in the NHS as a result of raising a concern in the public interest.

More: Policy and Strategy
Surgical same day emergency care

Remove: NHS Improvement source - 07 January 2020

The surgical same day emergency care (SSDEC) model builds on experience from established surgical ambulatory emergency care units and aims to bring principles learned from day surgery units for...

More: Case Studies
Updated Frequently Asked Questions issued regarding supply issue to people on home parenteral nutrition from Calea

Remove: NHS Improvement source - 06 January 2020 - Publisher: NHS Improvement

The updated FAQ highlights that the supply disruption is expected to continue for several more months and well into 2020. Work is underway to examine longer-term solutions for the supply of...

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Financial accounting and reporting updates

Remove: NHS Improvement source - 03 January 2020

NHS providers should refer to this page for the latest updates on financial accounting and reporting. We also email updates to finance teams.

More: Guidance
NHS Oversight Framework for 2019/20: provider trust segmentation

Remove: NHS Improvement source - 23 December 2019

Sets out the segmentation of NHS trusts and foundation trusts and the level of support we'll provide.

More: Guidance
NHS Engagement and Communications Development Programme

Remove: NHS Improvement source - 23 December 2019

We've designed this programme with NHS England to support NHS communicators across all levels.

More: Case Studies
Making data count

Remove: NHS Improvement source - 23 December 2019

These practical, interactive guides are suitable for those working at all levels in the NHS, from ward to board, and will show you how to make better use of your data.

More: Guidance
NHS Oversight Framework for 2019/20

Remove: NHS Improvement source - 23 December 2019

The NHS Oversight Framework for 2019/20 outlines the joint approach NHS England and NHS Improvement will take to oversee organisational performance and identify where commissioners and providers may...

More: Guidance
DRAFT National Tariff Payment System 2020/21: a consultation notice

Remove: NHS Improvement source - 19 December 2019 - Publisher: NHS Improvement

NHS England and NHS Improvement propose this DRAFT for the 2020/21 National Tariff Payment System; for which consultation is open until midnight at the end of 22 January 2020.

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National Patient Safety Alert - Risk of harm to babies and children from button batteries in hearing aids [PDF]

Remove: NHS Improvement source - 13 December 2019

For further detail, resources and supporting materials see: https://improvement.nhs.uk/news-alerts/risk-of-harm-to-babies-and-children- from-coin-butt

More: Safety Alerts
Audit and assurance — a guide to governance

Remove: NHS Improvement source - 13 December 2019

This guide provides information for providers and commissioners on good governance over audit and assurance.

More: Guidance
European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on license extension of ustekinumab (Stelara)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP recommended an extension to an existing indication; from treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 12 years and older, to patients 6...

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on license extension of bedaquiline (Sirturo)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP recommended an extension to the existing indication; from use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis in adults, to both adults and...

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on new pharmaceutical form with new indication of tafamidis (Vyndaqel)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

The CHMP adopted a positive opinion on use of tafamidis 61 mg soft capsules (currently only available as a 20mg capsule); for treatment of wild-type or hereditary transthyretin amyloidosis in adult...

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European Committee for Medicinal Products for Human Use issues positive opinion on approval of brolucizumab (Beovu) for treatment of neovascular (wet) age-related macular degeneration

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

Brolucizumab, an anti-neovascularisation agent, inhibits vascular endothelial growth factor A, suppressing endothelial cell proliferation, reducing pathological neovascularisation and decreasing...

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European Committee for Medicinal Products for Human Use issues positive opinion on approval of generic dexmedetomidine

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

Dexmedetomidine, a sedative agent acting as a selective alpha-2 receptor agonist, is currently only available as a branded product (Dexdor) for induction of light to moderate sedation of adults in...

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on new pharmaceutical form and strength of fosnetupitant / palonosetron (Akynzeo)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP adopted a positive opinion on use of Akynzeo 235 mg/0.25 mg solution for infusion for intravenous use. Currently, only Akynzeo 300mg/0.5mg hard capsules are available for prevention of nausea...

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on license extension of ramucirumab (Cyramza)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP adopted a positive opinion on use of ramucirumab in combination with erlotinib for first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal...

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on license extension of daratumumab (Darzalex)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP adopted a positive opinion on use of daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are...

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European Committee for Medicinal Products for Human Use issues positive opinion on approval of biosimilar adalimumab (Amsparity) for treatment of certain inflammatory and autoimmune disorders

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

Amsparity is considered highly similar to Humira (adalimumab) and data show that Amsparity has comparable quality, safety and efficacy to Humira. It is available as a 40 mg pre-filled syringe and pen...

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European Committee for Medicinal Products for Human Use issues positive opinion on approval of generic azacitidine

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

Azacitidine, a pyrimidine analogue, is currently only available as a branded product (Vidaza) for treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia.

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European Committee for Medicinal Products for Human Use issues positive opinion on approval of imipenem / cilastatin / relebactam (Recarbrio)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

This fixed dose-combination is intended to treat infections due to aerobic Gram-negative organisms in adults with limited treatment options. The most common side effect is diarrhoea.

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European Committee for Medicinal Products for Human Use issues (CHMP) positive opinion on license extension of fidaxomicin (Dificlir)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP recommended an extension to the existing indication; from treatment of Clostridioides difficile infections in adults, to both adult and paediatric patients with a body weight of at least 12.5 kg.

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European Committee for Medicinal Products for Human Use (CHMP) issues positive opinion on license extension of apalutamide (Erleada)

Remove: European Medicines Agency - EMA source - 13 December 2019 - Publisher: European Medicines Agency

CHMP adopted a positive opinion on use of apalutamide in adult men treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy.

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European Medicines Agency (EMA) update on metformin N-nitrosodimethylamine (NDMA) impurities

Remove: European Medicines Agency - EMA source - 06 December 2019 - Publisher: European Medicines Agency

EMA has confirmed that levels of NDMA in affected non-EU metformin are low and within or below the range that people can be exposed to from other sources e.g. certain foods/water. Authorities in the...

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New EMA infographic describes journey of a medicine

Remove: European Medicines Agency - EMA source - 05 December 2019 - Publisher: European Medicines Agency

This interactive timeline illustrates the journey of a medicine for human use authorised through European Medicines Agency, from initial research to discussions on patient access to medicines across...

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Structured query language (SQL) for statistical process control

Remove: NHS Improvement source - 29 November 2019

This test structured query language (SQL) script provides the basic foundations to create a simple statistical process control (SPC) individual moving range (XmR) chart.

More: Implementation Support
Risk of death and severe harm from ingesting superabsorbent polymer gel granules

Remove: NHS Improvement source - 29 November 2019 - Publisher: NHS Improvement

Granules are used to reduce spillage onto bedding/clothing when patients use urine bottles/vomit bowls, or when staff move fluid-filled containers. This Alert requires any organisation still using...

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Provisional publication of Never Events reported as occurring between 1 April and 31 October 2019 [PDF]

Remove: NHS Improvement source - 28 November 2019 - Publisher: NHS Improvement

There were 277 Never Events: 1 of IV med given epidurally, 4 of oral med given IV, 1 of oral med given subcut, 5 of methotrexate overdose prescribed and administered, 4 of overdose of insulin, 3 of...

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National Patient Safety Alert - Superabsorbent polymer gel granules (2019) [PDF]

Remove: NHS Improvement source - 28 November 2019

For further detail, resources and supporting materials see:improvement.nhs.uk/news-alerts/superabsorbent-polymer-gel-granules-2019 For any enquiries...

More: Safety Alerts
Improving joy at work — electronic self-rostering

Remove: NHS Improvement source - 28 November 2019

After realising the highest areas of turnover for nurses and midwives was the intensive care units, Royal Free London NHS Foundation Trust began a project to reduce turnover by improving joy at work.

More: Case Studies
A fair experience for all

Remove: NHS Improvement source - 21 November 2019

Our Workforce Race Equality Standard (WRES) team developed these resources to help support local practices in outlining targets for black and ethnic minority (BME) representation in leadership teams...

More: Case Studies
Responsible use of antibiotics: what's your role? [PDF]

Remove: European Medicines Agency - EMA source - 18 November 2019 - Publisher: European Medicines Agency

To mark European Antibiotic Awareness Day today, EMA launched a social media campaign to highlight the importance of using antibiotics responsibly.

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of solriamfetol (Sunosi) for treatment of narcolepsy and obstructive sleep apnoea [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor. The expected benefits are its ability to improve patients’ wakefulness and to reduce their daytime sleepiness.

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of fostamatinib (Tavlesse) for treatment of primary immune thrombocytopenia [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Fostamatinib blocks spleen tyrosine kinase, which plays a key role in antibody-mediated cellular responses, thereby reducing antibody-mediated destruction of platelets. Expected benefits include an...

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of clopidogrel / acetylsalicylic acid (Mylan) for secondary prevention of atherothrombotic events [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Clopidogrel/Acetylsalicylic acid Mylan is a bioequivalent generic of DuoPlavin, which has been authorised in the EU since 15 March 2010. It will be available as film-coated tablets (75 mg clopidogrel...

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Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for license extension of trastuzumab emtansine (Kadcyla) [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

The proposed license extension is for adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after...

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Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for license extension of lenalidomide (Revlimid) [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

The proposed license extension for lenalidomide is in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of osilodrostat (Isturisa) for treatment of Cushing's syndrome [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Osilodrostat inhibits 11-beta-hydroxylase (CYP11B1), an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. The expected benefits include the ability to control or...

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of siponimod (Mayzent) for treatment of multiple sclerosis [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Siponimod is a selective immunosuppressant acting as a sphingosine 1-phosphate receptor modulator on lymphocytes, thus reducing the recirculation of T-cells into the central nervous system and...

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Committee for Medicinal Products for Human Use (CHMP) recommends approval of polatuzumab vedotin (Polivy) for treatment of diffuse large B-cell lymphoma [PDF]

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

Polatuzumab vedotin is a CD79b targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent to B cells. Expected benefits, in combination with bendamustine and rituximab...

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Committee for Medicinal Products for Human Use (CHMP) to review sodium oxybate (Hopveus) for treatment of alcohol dependence

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

D&A Pharma has requested a re-examination of EMA’s October 2019 opinion which refused approval of the marketing authorisation due to concerns with the design and analysis of supporting studies and...

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PRAC recommendations for caution with tofacitinib endorsed by CHMP

Remove: European Medicines Agency - EMA source - 15 November 2019 - Publisher: European Medicines Agency

The recommendations that tofacitinib should be used with caution in patients with known risk factors for VTE, regardless of indication and dosage, have now been endorsed by Committee for Medicinal...

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Developing an education pathway for newly registered practitioners

Remove: NHS Improvement source - 14 November 2019

Great Ormond Street Hospital utilised evidence that if organisations can retain staff beyond their two years in the job, they are more likely to retain them for more than five years.

More: Case Studies

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Results for all evidence | European Medicines Agency - EMA 1 - 50 of 3229 sorted by relevance / date

National Patient Safety Alert - Risk of harm to babies and children from button batteries in hearing aids [PDF]

Provisional publication of Never Events reported as occurring between 1 April and 31 October 2019 [PDF]

National Patient Safety Alert - Superabsorbent polymer gel granules (2019) [PDF]

Responsible use of antibiotics: what's your role? [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of solriamfetol (Sunosi) for treatment of narcolepsy and obstructive sleep apnoea [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of fostamatinib (Tavlesse) for treatment of primary immune thrombocytopenia [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of clopidogrel / acetylsalicylic acid (Mylan) for secondary prevention of atherothrombotic events [PDF]

Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for license extension of trastuzumab emtansine (Kadcyla) [PDF]

Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for license extension of lenalidomide (Revlimid) [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of osilodrostat (Isturisa) for treatment of Cushing's syndrome [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of siponimod (Mayzent) for treatment of multiple sclerosis [PDF]

Committee for Medicinal Products for Human Use (CHMP) recommends approval of polatuzumab vedotin (Polivy) for treatment of diffuse large B-cell lymphoma [PDF]