Search results for "CATALOG"

Trends in individual reimbursement of orphan drugs in Latvia in 2008–2011

2014

Orphan drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than 5 in 10 000 people in the European Union (EU). These drugs are called “orphans” because the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing products intended for only a small number of patients suffering from very rare conditions. Because of the small market, ODs are often very expensive. Whereas decisions surrounding orphan designation and marketing authorization of ODs are taken at the EU level, decisions governing pricing and reimbursement of ODs are a member state responsibility…

OHP-041 Formulary Decision-Making For Biosimilars: Considerations For Hospital Pharmacists

2013

Background It has been 6 years since the first biosimilar was approved for use in the European Union (EU). Given the likelihood that biosimilar monoclonal antibodies will be approved in Europe in the near future, it is timely to review the formulary selection criteria for biologicals and biosimilars. The European Medicines Agency (EMA) has issued guidelines that define the regulation of biosimilars in Europe and recommend approaches to establish biosimilarity. However, several questions regarding the assessment of biosimilars for formulary inclusion remain unanswered, including those related to manufacturing and drug supply. Purpose To aid hospital pharmacists in developing evaluation crite…

Motor Vehicles Not Used in Road Traffic Are Also Subject to Compulsory Insurance in Europe - CJEU Clarification in Case C-80/17

2019

The article analyses a recent significant case in the Court of Justice of the European Union on the extent of compulsory insurance in the field of motor insurance. The judgment delivered by the Grand Chamber of the CJEU on 04 September 2018 clarifies the obligation to conclude a motor insurance contract in a situation when a motor vehicle is no longer intended to be used in road traffic. If previously there was no doubt that motor vehicles that are used in road traffic are subject to compulsory insurance, it was unclear whether compulsory insurance in the field of motor insurance also extends to vehicles which are no longer intended to be used in road traffic. The Court formulated the ‘thre…

Mediación en derecho administrativo

2018

Presenciamos un momento de creciente fascinación por la mediación. Sin embargo, el Derecho administrativo se presenta históricamente como un ámbito plagado de obstáculos frente a las ADR y, por tanto, frente a la mediación. Sin embargo, los cambios sociales y la mutación de las estructuras administrativas llevan a buscar nuevos cauces para la resolución de los conflictos con la Administración. La mediación se ha visto fuertemente impulsada por la Unión Europea y en el ámbito interno, el Consejo General del Poder Judicial ha propiciado la incorporación de la mediación administrativa mediante proyectos pilotos que impulsan el consenso.

Pertussis vaccines--1993.

1993

New Modes of Regulation for Health and Safety: Post-Enlargement Policy Perspectives for the European Union

2006

The recent joining of ten new member states to the European Union, eight of which are former communist countries, has reopened inherent tensions in current European Union (EU) policy-making on safety and health in the workplace. These spring from seemingly incompatible objectives; the need to ensure broad EU member state compliance with regulation, around agreed minimum standards through active regulatory enforcement, and the promotion of “softer” voluntary initiatives in the management of workplace risks and hazards in order to create “a culture of prevention.” The present EU strategy which ends in 2006, seeks to secure a balance between both sets of objectives. However, with respect to t…

Plasma viscosity and related cardiovascular risk factors in a Spanish Mediterranean population

2006

Plasma viscosity (PV) constitutes an independent important predictor of initial and recurrent cardiac events and mortality. It has been suggested that there is a geographical variation in PV values related to coronary event rates. Little information exists regarding PV in Spain. Therefore, our objective was to determine PV in a large sample of randomly selected subjects from the Spanish population and to study which demographic or cardiovascular risk factors (CVRF) influence levels of PV in this population.1277 subjects (503 males, 774 females) aged 43+/-14 years (range: 20-70) were randomly selected from an Eastern Spanish population. These subjects were free of cardiovascular diseases and…

Histological Features of Cerebellar Neuropathology in Patients With Alcoholic and Nonalcoholic Steatohepatitis

2018

Alcoholic steatohepatitis (ASH) and nonalcoholic steatohepatitis (NASH) affect 29 million people in the European Union. Patients with ASH and NASH may exhibit cognitive impairment, reducing their quality of life. Steatohepatitis induces cerebral alterations. It is not known if histological analysis could allow distinguishing ASH, NASH, and/or cirrhosis neuropathology and other entities. The aim of this work was to analyze a set of histopathological features characterizing the brain lesions due to ASH, NASH, and cirrhosis. We performed a histological study using hematoxylin and eosin staining and immunohistochemical techniques in cerebellum of 31 subjects who died with healthy liver (n = 6),…

Nationwide analysis on the impact of socioeconomic land use factors and incidence of urothelial carcinoma

2017

Incidence rates for urothelial carcinoma (UC) have been reported to differ between countries within the European Union (EU). Besides occupational exposure to chemicals, other substances such as tobacco and nitrite in groundwater have been identified as risk factors for UC. We investigated if regional differences in UC incidence rates are associated with agricultural, industrial and residential land use.Newly diagnosed cases of UC between 2003 and 2010 were included. Information within 364 administrative districts of Germany from 2004 for land use factors were obtained and calculated as a proportion of the total area of the respective administrative district and as a smoothed proportion. Fur…

Neddylation inhibition ameliorates steatosis in NAFLD by boosting hepatic fatty acid oxidation via the DEPTOR-mTOR axis

2021

Objective Neddylation is a druggable and reversible ubiquitin-like post-translational modification upregulated in many diseases, including liver fibrosis, hepatocellular carcinoma, and more recently, non-alcoholic fatty liver disease (NAFLD). Herein, we propose to address the effects of neddylation inhibition and the underlying mechanisms in pre-clinical models of NAFLD. Methods Hepatic neddylation measured by immunohistochemical analysis and NEDD8 serum levels measured by ELISA assay were evaluated in NAFLD clinical and pre-clinical samples. The effects of neddylation inhibition by using a pharmacological small inhibitor, MLN4924, or molecular approaches were assessed in isolated mouse hep…