PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002462 November 28, 2017
Published: February 23, 2010
https://doi.org/10.1371/journal.pmed.1000235
Volume 7 | Issue 2 | e1000235
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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Research Article
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002625 July 31, 2018 / 1-19
PLOS Medicine | DOI:10.1371/journal.pmed.1002088 August 23, 2016
3rd edition!Large File 17 MB!
First edition, November 1997 | Revised July 2002
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Guidance for the preparation and submission of dossiers
23 April 2020EMA/202483/2020 Rev
Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart.
The European Medicines Agency (EMA) is evaluating potential COVID-19 treatments and vaccines to enable promising medicines to reach patients as soon as possible. It is also interacting with medicine developers and making use of real-world data to monitor the safety and effectiveness of medicines use...d in patients with COVID-19.
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An overview of COVID-19 Vaccine AstraZeneca and why it is authorised in the EU. Available in 22 languages
18 Febr. 2021