Data from FDA - Curated by EPG Health - Last updated 31 August 2017
Indication(s)
Learning Zones
An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.
Acute and Advanced Heart Failure
What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...
+ 3 more
Alkaline Phosphatase (ALP) Lab Assessment
Discover an overview of hypophosphatasia and details required to facilitate the timely and accurate detection of low alkaline phosphatase.
Allergic Rhinitis
Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.
+ 4 more
Atopic Dermatitis
The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.
Biosimilars in Oncology Knowledge Centre
What are biologics and how do they differ from small molecule medicines? Discover more about their development, as well as the manufacturing and regulatory processes in the Biosimilars in Oncology Knowledge Centre.
Cardiovascular Metabolism Knowledge Centre
The Cardiovascular Metabolism Knowledge Centre is an information hub providing expert insight into the management of hypertension and type 2 diabetes. This Knowledge Centre contains a wealth of scientific video content offering insights and opinion from some of the leading experts in the field.
Chronic Lymphocytic Leukaemia (CLL)
Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more
+ 1 more
Chronic Obstructive Pulmonary Disease (COPD)
View highlights from recent congresses presented in new expert videos with leading physicians.
+ 7 more
Related Content
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
Added 16 days ago
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus...
Added 16 days ago
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF)...
Added 16 days ago
ALTA-1L Study: A Phase 3 Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-small Cell Lung Cancer (NSCLC) Participants (ALTA-1L)
The purpose of this phase III, randomized, open-label, comparative, multicenter, international study is to compare the efficacy and safety of brigatinib to that of crizotinib in ALK-positive locally advanced or metastatic NSCLC...
Added 17 days ago
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
The primary study hypothesis is that pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free survival and overall survival compared to standard treatment.
Added 17 days ago
Association Between Baseline LDL-C Level and Total and Cardiovascular Mortality After LDL-C Lowering: A Systematic Review and Meta-analysis.
Objective: To evaluate whether baseline LDL-C level is associated with total and cardiovascular mortality risk reductions.
Added 16 days ago
Efficacy and Safety of Further Lowering of Low-Density Lipoprotein Cholesterol in Patients Starting With Very Low Levels: A Meta-analysis.
Objective: To evaluate efficacy and safety of further lowering LDL-C levels in patient populations presenting with median LDL-C levels of 1.8 mmol/L (70 mg/dL) or less.
Added 16 days ago
Safety and efficacy of the reducer: A multi-center clinical registry - REDUCE study.
The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies.
Added 16 days ago
Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial.
We aimed to investigate the efficacy and safety of apomorphine infusion compared with placebo in patients with Parkinson's disease with persistent motor fluctuations despite optimised oral or transdermal treatment.
Added 16 days ago
Global Prospective Safety Analysis of Rivaroxaban.
This study sought to assess the real-world safety profile of rivaroxaban through a pooled analysis of patients with AF enrolled in the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) program worldwide.
Added 16 days ago
Recurrent pregnancy loss
The overall aim of this guideline is to supply healthcare providers with the best available evidence for investigation and treatment of women with recurrent pregnancy loss.
Added 1 month ago
Recommendations for the Surgical Treatment of Endometriosis. Part 1: Ovarian Endometrioma
This document provides recommendations covering technical aspects of different methods of surgery for endometriomas in women of reproductive age.
Added 1 month ago
International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018
Objective: To develop and translate rigorous, comprehensive evidence-based diagnosis, assessment and treatment guidelines, to improve the lives of women with polycystic ovary syndrome (PCOS) worldwide.
Added 1 month ago
EACS GUIDELINES Version 9.0 October 2017
EACS produces the European Guidelines for treatment of HIV-positive adults in Europe.
Added 2 months ago
Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management
The guideline has been condensed into two papers,[...] the second describing current therapeutic management [treatment of active disease and maintenance of medically induced remission].
Added 3 months ago
More information
| Category | Value |
|---|---|
| Agency product number | 8P5F881OCY |
| Orphan designation | No |
| Product NDC | 51079-621 |
| Date Last Revised | 27-09-2012 |
| Type | HUMAN PRESCRIPTION DRUG |
| RXCUI | 1545801 |
| Marketing authorisation holder | Mylan Institutional Inc. |