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PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Halaven" RSS

12:54 EST 17th November 2019 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Halaven" PubMed Articles 1–25 of 44,000+

Cost-effectiveness of public health interventions against human influenza pandemics in France: a methodological contribution from the FLURESP European Commission project.

The FLURESP project is a public health project funded by the European Commission with the objective to design a methodological approach in order to compare the cost-effectiveness of existing public health measures against human influenza pandemics in four target countries: France, Italy, Poland and Romania. This article presents the results relevant to the French health system using a data set specifically collected for this purpose.


The financial burden of non-communicable diseases in the European Union: a systematic review.

Non-communicable diseases (NCDs) impose a significant and growing burden on the health care system and overall economy of developed (and developing) countries. Nevertheless, an up-to-date assessment of this cost for the European Union (EU) is missing from the literature. Such an analysis could however have an important impact by motivating policymakers and by informing effective public health policies.

Corrigendum to: Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List.


Does public report card matter? A 10-year interrupted time series analysis on total knee replacement.

There is a lack of evidence that shows whether a report card can improve health outcomes in terms of infection rates or unscheduled readmission by using rigorous methods to evaluate its impact.

The Impact of Price Negotiations on Public Procurement Prices and Access to 8 Innovative Cancer Medicines in a Middle-Income Country-The Case of Mexico.

To mitigate the effect of high prices, in 2008 Mexico established a commission that negotiates single procurement prices for patented medicines in the public sector.

Assessment of technical efficiency of public hospitals in Turkey.

Turkish public hospitals have been subjected to health care reform because of increasing cost pressure, inequities in access to health care, poor quality of care and limited patient responsiveness in the last three decades. This study investigates the impact of recent hospital reforms on the efficiency of public hospitals.

The European Medicines Agency's scientific opinion on oral fexinidazole for human African trypanosomiasis.

Mutual recognition in the European system: A blueprint for increasing access to medicines?

The European regulatory system for approval of medicinal products is globally recognised as a unique platform for regulatory work-sharing and mutual recognition. As such, it potentially serves as a role model for regulatory capacity building worldwide. While focusing on mutual recognition and decentralised procedures, this paper illustrates key success factors and structures allowing for the reliance-based authorisation of medicines in the European Economic Area from the perspective of a national regulatory...

A Quantitative Public Health Risk Assessment Tool for Planning for At-Risk Populations.

The Drexel University Center for Public Health Readiness and Communication developed a quantitative public health risk assessment tool that has been used in Pennsylvania and across the United States. The tool assesses hazard impacts on health care and public health metrics and incorporates the planning needs of at-risk populations. The flexible platform using Microsoft Excel allows planners to customize hazard assessment and use jurisdiction-specific data. Findings from the risk assessment can guide plannin...

Access to and use of medicines in the Annapurna region of Western Nepal and possible impacting factors.

Improving access to medicines is a major healthcare challenge for low-income countries because the problem traverses health systems, society and multiple stakeholders. The Annapurna region of Nepal provides a valuable case study to investigate the interplay between medicines, society and health systems and their effects on access to and use of medicines. Government health facilities and international aid organizations provide some healthcare in the region, communities participate actively in healthcare orga...

Public engagement in health technology assessment in Brazil: the case of the Trastuzumab public consultation.

Public engagement in health technology assessment (HTA) is increasing worldwide. There are several forms of public engagement and it is not always possible to determine which stakeholders participate in the HTA process and how they contribute. Our objective was to investigate which types of social representatives contributed to the public consultation on the incorporation of Trastuzumab for early-stage breast cancer treatment within the public health system in Brazil, held in 2012 by the National Committee ...

Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

Given that cardiovascular safety concerns remain the leading cause of drug attrition at the preclinical drug development stage, the National Center for Toxicological Research of the US Food and Drug Administration hosted a workshop to discuss current gaps and challenges in translating preclinical cardiovascular safety data to humans. This white paper summarizes the topics presented by speakers from academia, industry, and government intended to address the theme of improving cardiotoxicity assessment in dru...

Kidney graft survival of >25 years: A single center report including associated graft biopsy results.

We appreciate the valuable comments to our report. Epitope matching or total eplet mismatch could indeed be an attractive explanation for the favorable outcome of the subjects in our report, at least for those without rejection. This relatively novel view of immunological assessment could be very important although its true value remains to be determined.

Towards a "prescribing license" for medical students: development and quality evaluation of an assessment for safe prescribing.

This report describes the development and validation process of an assessment with national consensus in appropriate and safe pharmacotherapy.

A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines.

European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe.

Hospital pharmacists call for European action to combat medicines shortages.

The implementation of RAAF in the OECD QSAR toolbox.

The Read-Across Assessment Framework (RAAF) was developed by the European Chemical Agency (ECHA) as an internal tool providing a framework for a consistent, structured and transparent assessment of grouping of chemicals and read-across. Following a RAAF-based evaluation, also developers and users of read-across predictions outside ECHA can judge whether their read-across rationale is sufficiently robust from a regulatory perspective. The aim of this paper is to describe the implementation of RAAF functional...

Evaluation of prices, availability and affordability of essential medicines in Lahore Division, Pakistan: A cross-sectional survey using WHO/HAI methodology.

Inadequate access to medicines affected by un-controlled prices is a major concern in developing countries, including Pakistan, which lacks comprehensive data on medicine prices. Thus, the objective of this study was to evaluate the prices, availability and affordability of essential medicines in Lahore division, Pakistan. The survey was undertaken from November, 2016 till March, 2017 by including 50 medicines, 14 from the WHO/HAI core list and 36 supplementary medicines from national essential medicine lis...

Industrial perceptions of medicines regulatory harmonization in the East African Community.

Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration o...

How to Harness Big Data for the Benefit of Patients.

IMI is a large public private partnership which has committed Euro 5 Billion from the European Commission, the European Pharmaceutical sector and other partners, to enable and accelerate bringing medical innovation to patients. IMI is now 10 years old and already has changed the ecosystem and way of working in developing innovative medicines across the public/private divide. Big data represents a significant piece of this investment and projects in this area are attempting to provide solutions to major chal...

Comparative analysis of sublingual immunotherapy medicines for adherence and clinical outcomes.

Sublingual immunotherapy (SLIT) has been considered as an effective and safe alternative to the subcutaneous route. However, different modalities and administration methods may lead to significant changes in their adherence and clinical outcomes. The purpose of this study was to compare the adherence, efficacy, and side effects of SLIT medicines: SLITone, Lais, and Staloral.

Access to Cancer Precision Medicines in Switzerland: A Comparative Analysis (USA and EU) and Health Policy Implications.

Social health insurance is mandatory in Switzerland and covers the costs of basic medical care. In general, with regard to medicines, the costs are only reimbursed if the drug is (1) approved by Swissmedic and (2) listed on the so-called Spezia-litätenliste (SL) by the Federal Office of Public Health (FOPH). However, the SL does not include all drugs. For non-SL drugs, cost coverage is only granted under exceptional circumstances. Absence of cost coverage by social health insurance is especially problemati...

Availability of Effective Evidence-Based Symptomatic Treatments for Cluster Headache in the EU Countries-A Survey of the European Headache Alliance and European Headache Federation.

To assess the reimbursement options and accessibility of three effective medicines for cluster headache (CH) (subcutaneous sumatriptan, oxygen, and zolmitriptan spray) across the European Union (EU).

Selection of WHO-recommended essential medicines for non-communicable diseases on National Essential Medicines Lists.

Non-communicable diseases (NCDs) are the leading cause of death worldwide. Inadequate and inequitable access to essential NCD medicines is a major concern, particularly in low- and middle-income countries. National Essential Medicines Lists (EMLs) are important policy tools that indicate which medicines are prioritized as essential within a country's health system. This study sought to analyze a wide range of national essential medicines lists (EMLs) for their inclusion of priority non communicable disease ...

European Public Health News.


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