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Showing "Human medicines European public assessment report EPAR Zynquista" 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.

Rapid assessment of enhanced safety surveillance for influenza vaccine.

The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.

European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective.

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.

Added value of human biomonitoring in assessment of general population exposure to xenobiotics.

Human biomonitoring (HBM) has a wide range of applications and long tradition both in health care and the field of public health. Its major advantage is the integration of all exposure routes and sources. Since HBM information is an integrated exposure finding it offers the opportunity to trace and mimic a realistic exposure scenario. It reduces the number of assumptions that need to be made when estimating exposure and thus helps to reduce the uncertainties in exposure science. In spite of some challenges,...

Storage of prescription veterinary medicines on UK dairy farms: a cross-sectional study.

Prescription veterinary medicine (PVM) use in the UK is an area of increasing focus for the veterinary profession. While many studies measure antimicrobial use on dairy farms, none report the quantity of antimicrobials stored on farms, nor the ways in which they are stored. The majority of PVM treatments occur in the absence of the prescribing veterinarian, yet there is an identifiable knowledge gap surrounding PVM use and farmer decision making. To provide an evidence base for future work on PVM use, data ...

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...

Evolution of Average European Medicine Prices: Implications for the Methodology of External Price Referencing.

There are indications of staggered market entry of medicines in the national markets, with medicines being marketed first in countries with high prices. This study aimed to analyse the availability and evolution of medicine prices in the European Union (EU).

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...

Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015.

The introduction provisional approval strategies increases the approval of anticancer drugs with ambiguous benefit-risk profiles. Thus, in many instances, there is lacking evidence about overall survival (OS) at the time of marketing authorisation. Our objective was to monitor and characterise therapies with ambiguous benefit-risk profiles and identify any postapproval updates on median OS after at least 3 years of approval by the European Medicines Agency (EMA).

The availability, prices and affordability of essential medicines in Malawi: A cross-sectional study.

The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.

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.

Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey.

HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world's largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic.

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.

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...

"You've got to breathe, you know" - asthma patients and carers' perceptions around purchase and use of asthma preventer medicines.

To explore influences on patients' purchase and use of asthma preventer medicines and the perceived acceptability of financial incentives via reduced patient co-payments.

An insight into Z-drugs abuse and dependence: an examination of reports to the European Medicines Agency (EMA) database of suspected Adverse Drug Reactions (ADR).

Although originally marketed as safe alternatives to the habit-forming benzodiazepines, growing numbers of zaleplon, zolpidem, and zopiclone ('Z-drugs') clinical concerns relating to their potential of abuse, dependence and withdrawal have been reported overtime.  We aimed here at assessing these issues analysing datasets of Adverse Drug Reactions (ADR) provided by the European Medicines Agency (EMA) through the EudraVigilance (EV) system.

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...

Investigation of medicines consumption and disposal in Brazil: A study case in a developing country.

The incorrect disposal of medicines can be harmful to the environment. Here, we aim to understand the consumption and disposal of medicines in Brazil using online forms. 64% of the respondents have the habit to self-medicate. 66% of respondents dispose the disused or expired medicines in the garbage. 71.9% of respondents never receive any information about correct disposal of medicines. 95.2% of respondents believe that residues of medicines can be harmful to the environment. Environmental education can pro...

HIV in Canada-Surveillance Report, 2017.

Human immunodeficiency virus (HIV) is a global public health issue with an estimated 1.8 million people newly infected in 2017.

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...

The State Scientific Automated Medical Registry, Kazakhstan: an important resource for low-dose radiation health research.

Direct quantitative assessment of health risks following exposure to ionizing radiation is based on findings from epidemiological studies. Populations affected by nuclear bomb testing are among those that allow such assessment. The population living around the former Soviet Union's Semipalatinsk nuclear test site is one of the largest human cohorts exposed to radiation from nuclear weapons tests. Following research that started in the 1960s, a registry that contains information on more than 300,000 individu...

Evaluation of the factor structure of the Canine Behavioural Assessment and Research Questionnaire (C-BARQ) in European Portuguese.

The human-dog relationship is thought to be the oldest domestic animal partnership. These relationships are complex and can become problematic when they become dysfunctional. The most common signs of dysfunctional human-dog partnerships are behaviour problems that, when unidentified and uncorrected, can be a clear danger to both species and the public. The Canine Behavioural Assessment and Research Questionnaire (C-BARQ) is a widely implemented instrument to evaluate dog behaviour proven to be useful across...

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