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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte
...
d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Diarrhea is one of the world’s leading causes of child illness and death, and rotavirus is the most common cause of severe diarrhea. Yet it can be prevented and treated. There is a vaccine. And while hundreds of thousands of children in India will gain access to rotavirus vaccines -part of a natio
...
nal introduction marking Asia’s largest so far -millions of children globally still lack access. This new report from the Rota Council summarizes the latest evidence on rotavirus disease and vaccines and identifies 21 recommendations for stakeholders to scale up coverage and prevent hundreds of thousands of child deaths annually.
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3 March 2016
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was
...
to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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Guideline ‒ Alternative mass drug administration regimens to eliminate lymphatic filariasis
recommended
Lymphatic filariasis is a vector-borne neglected tropical disease that causes damage of the lymphatic system and can lead to lymphoedema (elephantiasis) and hydrocele in infected individuals. The global baseline estimate of persons affected by lymphatic filariasis is 25 million men with hydrocele an
...
d over 15 million people with lymphoedema. At least 36 million persons remain with these chronic disease manifestations. The disease is endemic in 72 countries. In 2016, an estimated total population of 856 million were living in areas with ongoing transmission of the causative filarial parasites and requiring mass drug administration (MDA). Lymphatic filariasis disfigures and disables, and often leads to stigmatization and poverty. Hundreds of millions of dollars are lost annually due to reduced productivity of affected patients. WHO has ranked the disease as one of the world’s leading causes of permanent and long-term disability.
more
Accessed November 2017
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
Division of Tuberculosis Elimination.
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
Rewiew Article
Hindawi Publishing Corporation, Tuberculosis Research and Treatment; Volume 2011, Article ID 712736, 6 pages, doi:10.1155/2011/712736
Interferon-γ Assays - Description and Assessment of a New Tool in the Diagnosis of Tuberculosis.
Haür B et al. Interferon-γ-Tests in der ...Pneumologie 2006; 60: 29-44
Replacement of Annex 2 of WHO Technical Report Series, No. 964
...
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This revised trainer's guide contains a prototype training schedule for four days. Teaching and learning strategies are highly interactive, using participatory and experiential approach. Training outcomes include developing skills in assessment of clients for risk factors; conduct basic screening pr
...
ocedures and interpreting the results; holding health education sessions on risk factor modification; promoting healthy lifestyle; and mobilizing communities. The manual is divided into six modules.
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SAGE-Hindawi Access to Research Autoimmune Diseases
Volume 2011, Article ID 937586, 5 pages doi:10.4061/2011/937586
Mood disorders
Chapter E.2
