Use of non-steroidal anti-inflammatory drugs in porcine health management

2019 ◽  
Vol 185 (6) ◽  
pp. 172-172
Author(s):  
Alexandra Schoos ◽  
Mathias Devreese ◽  
Dominiek GD Maes
Keyword(s):  
European Union ◽  
Pain Management ◽  
Sodium Salicylate ◽  
Health Management ◽  
European Medicines Agency ◽  
The European Union ◽  
Treatment Regimens ◽  
Experimental Inflammation ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

ObjectiveTreatment of inflammation and pain management is an important topic in the welfare of pigs. It is very difficult for veterinary practitioners to choose the most appropriate product for a certain problem. This review aims to summarise and discuss the characteristics of different non-steroidal anti-inflammatory drugs (NSAIDs), as well as paracetamol and metamizole, available for pigs in the European Union.MethodsThe databases Pubmed, Google Scholar, CliniPharm CliniTox and European Medicines Agency were searched. Relevant terms (eg,‘meloxicam’, ‘fever’, ‘swine’, ‘pig’, ‘inflammation’, ‘castration’, ‘pain’) were used to search for original articles, reviews and books. Only peer-reviewed articles were used. References from studies were also analysed in order to find additional relevant studies.ConclusionStudies which have investigated the efficacy of NSAIDs for different conditions, using different treatment regimens, are scarce. Most studies focused on the efficacy of NSAID-related pain alleviation in piglet castration, as well as the anti-inflammatory potential of NSAIDs in experimental inflammation models. Little research has been carried out on the use of metamizole, tolfenamic acid, paracetamol and sodium salicylate and their effect in pigs.

scholarly journals The latest orphan drug designations and the Commission Communication on Regulation (EC) 141/2000

2005 ◽  
Vol 11 (3) ◽  
Author(s):  
Rashmi R Shah
Keyword(s):  
European Union ◽  
Rare Diseases ◽  
European Medicines Agency ◽  
Biological Plausibility ◽  
The European Union ◽  
Medicinal Products ◽  
Market Exclusivity ◽  
Community Regulation ◽  
Orphan Medicinal Products ◽  
Patient Groups

The implementation of Community Regulation on orphan medicinal products in the European Union in April 2000 has resulted in a deluge of applications for designation of medicinal products as orphan for rare diseases. By April 2004, the Committee for Orphan Medicinal Products had already given positive opinion on 63 per cent of the 316 applications considered by them. A significant number of these positive designations have already matured into full marketing authorisations. Three major reasons – failure to meet prevalence or significant benefit criteria or provide evidence of biological plausibility – have equally contributed to either the negative opinion on or the applicants withdrawing the remaining applications. In July 2004, the European Commission issued a communication setting out its position on certain matters relating to the implementation of the designation and market exclusivity provisions. The Commission, the European Medicines Agency (EMEA) and the Committee for Orphan Medicinal Products (COMP) continue to be proactive and provide as much guidance and incentives as practical, engaging themselves with sponsors, patient groups and academia. As experience builds up and issues are clarified, there are expectations that the Community Regulation on orphan medicines will prove to be a spectacular success.

scholarly journals Assessment of HIV molecular surveillance capacity in the European Union, 2016

2017 ◽  
Vol 22 (49) ◽  
Author(s):  
Patrick Keating ◽  
Anastasia Pharris ◽  
Katrin Leitmeyer ◽  
Stefania De Angelis ◽  
Annemarie Wensing ◽  
...  
Keyword(s):  
European Union ◽  
Sequence Data ◽  
National Level ◽  
Antiretroviral Drugs ◽  
Surveillance Systems ◽  
European Economic Area ◽  
The European Union ◽  
Molecular Surveillance ◽  
Treatment Regimens ◽  
Immunodeficiency Syndrome

Introduction Expanding access to HIV antiretroviral treatment is expected to decrease HIV incidence and acquired immunodeficiency syndrome (AIDS) mortality. However, this may also result in increased HIV drug resistance (DR). Better monitoring and surveillance of HIV DR is required to inform treatment regimens and maintain the long term effectiveness of antiretroviral drugs. As there is currently no formal European Union (EU)-wide collection of HIV DR data, this study aimed to assess the current HIV molecular surveillance capacity in EU/European Economic Area (EEA) countries in order to inform the planning of HIV DR monitoring at EU level. Methods: Thirty EU/EEA countries were invited to participate in a survey on HIV molecular surveillance capacity, which also included laboratory aspects. Results: Among 21 responding countries, 13 reported using HIV sequence data (subtype and/or DR) for surveillance purposes at national level. Of those, nine stated that clinical, epidemiological and sequence data were routinely linked for analysis. Discussion/conclusion: We identified similarities between existing HIV molecular surveillance systems, but also found important challenges including human resources, data ownership and legal issues that would need to be addressed. Information on capacities should allow better planning of the phased introduction of HIV DR surveillance at EU/EEA level.

PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?

2021 ◽  
Vol 37 (S1) ◽  
pp. 19-19
Author(s):  
Nadine Henderson ◽  
Phill O'Neill ◽  
Martina Garau
Keyword(s):  
European Union ◽  
Western Europe ◽  
European Countries ◽  
Marketing Authorization ◽  
European Medicines Agency ◽  
The European Union ◽  
The Public ◽  
Orphan Medicinal Products ◽  
Medicines Regulation ◽  
Canadian Provinces

IntroductionThe European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.MethodsData were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).ResultsSince the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.ConclusionsWe observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.

Nonsteroidal Anti-Inflammatory Drugs in Perisurgical Pain Management

Drugs ◽  
1995 ◽  
Vol 49 (1) ◽  
pp. 51-70 ◽  
Author(s):  
Jeremy Cashman ◽  
Gregory McAnulty
Keyword(s):  
Pain Management ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

Pharmaceutical Regulation in the European Union

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
European Union ◽  
Drug Approval ◽  
Good Clinical Practice ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Regulatory Regime ◽  
The European Union ◽  
Regulatory Pathways

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.

Challenges to sovereign ambitions: forces of convergence and divergence within the global pharmaceutical sector and the UK's withdrawal from the European Union

2020 ◽  
pp. 1-17
Author(s):  
John S. F. Wright ◽  
Dimitrios Doukas
Keyword(s):  
European Union ◽  
The United States ◽  
The European Union ◽  
Pharmaceutical Sector ◽  
Pharmaceutical Markets ◽  
Regulatory Governance ◽  
Treatment Regimens ◽  
Legal Challenges ◽  
New Treatment ◽  
Market Pressures

Abstract This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

Redefining the Treatment Paradigm for Post-operative Inflammation Control – The Role of Topical Non-steroidal Anti-inflammatory Drugs

2010 ◽  
Vol 04 (01) ◽  
pp. 54 ◽  
Author(s):  
Oliver Findl ◽  
Keyword(s):  
Current Treatment ◽  
Ocular Inflammation ◽  
Cystoid Macular Oedema ◽  
European Medicines Agency ◽  
Pharmacological Properties ◽  
New Agents ◽  
Treatment Paradigm ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

Topical ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) are used in the treatment of post-operative ocular inflammation and pain following cataract surgery and for some other clinical applications of ophthalmology, including cystoid macular oedema. Products vary by their pharmacological properties, clinical efficacy and tolerability, which affect their place in therapy for new agents in Europe. The pharmacological properties of topical ophthalmic NSAIDs and their place in current treatment of post-operative ocular inflammation are discussed in this article, focussing on bromfenac, which has been submitted for approval by the European Medicines Agency (EMEA).

scholarly journals Etyczne i prawne aspekty stosowania preparatu medycznego ellaOne czyli tzw. pigułki „pięć dni później”

2015 ◽  
Vol 13 (1) ◽  
pp. 9-34
Author(s):  
Andrzej Kobyliński
Keyword(s):  
European Union ◽  
Medicinal Product ◽  
Human Life ◽  
Legal Aspects ◽  
European Medicines Agency ◽  
The European Union ◽  
Medical Prescription ◽  
Postcoital Contraception ◽  
Emergency Contraceptive ◽  
The Eu

The article focuses on ethical and legal aspects of the use of the postcoital contraception. In November 2014, The European Medicines Agency recommended a change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne. This medicinal product has been authorized in the European Union since 2009. The European Medicines Agency found that ellaOne could be used safely and effectively without medical prescription, which means that this medicinal product could be obtained without a prescription in the EU. The decision opens up a new stage of public debate about the beginnings of human life and recognition of the human embryo as a human being from the very moment of conception.

scholarly journals The safety of nonsteroidal anti-inflammatory drugs in population-based studies: the benefits of aceclofenac

2020 ◽  
Vol 14 (4) ◽  
pp. 138-143
Author(s):  
E. Yu. Pogozheva ◽  
A. E. Karateev ◽  
V. N. Amirdzhanova
Keyword(s):  
Randomized Clinical Trials ◽  
Population Based ◽  
Minimal Risk ◽  
The European Union ◽  
Analgesic Effects ◽  
Quality Of Medical Care ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Effective Pain Relief ◽  
Meta Analyses

Effective pain relief in rheumatology practice is one of the most important criteria for the quality of medical care. Therefore, drugs with analgesic effects, primarily nonsteroidal anti-inflammatory drugs (NSAIDs), are among the most commonly used ones in the combination therapy of rheumatic diseases. All NSAIDs are capable of causing to one degree or another extent unwanted reactions that occur in the gastrointestinal tract (GIT), cardiovascular system (CVS), liver, kidneys, and allergic reactions. Considering the widespread use of NSAIDs, the problem of preventing these complications becomes not only medical, but also social. In 2008, the European Union launched the international project SOS (Safety Of non-Steroidal anti-inflammatory drugs) to study the safety of NSAIDs. The results of this project have shown that aceclofenac is one of the most successful drugs in combining the safety for GIT and CVS. Compared with other NSAIDs, this drug has a minimal risk for GI bleeding (relative risk (RR) 1.43; 95% confidence interval (CI), 0.65–3.15); it does not increase the risk of hospitalization for heart failure (RR, 1.03; 95% CI, 0.91–1.15) or the risk of developing myocardial infarction (RR 1.04; 95% CI, 0.90–1.19) either. The risk of ischemic stroke during aceclofenac therapy was slightly increased (RR, 1.17); but statistically insignificant (95% CI, 0.98–1.39). A large number of randomized clinical trials, meta-analyses, and observational programs have demonstrated that aceclofenac has pronounced analgesic and anti-inflammatory effects that are comparable to those of other NSAIDs and can be used in diseases accompanied by musculoskeletal pain, including that in older patients.

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