Prakt. lékáren. 2010; 6(3): 139-143

Orphan drugs

PharmDr.Vítězslava Fričová, Mgr.Kristýna Fričová
Phoenix, Farmaceutický informační servis, Brno

Despite the indisputable development and increase in the availability of new drugs all around the world, the therapy of some diseases is

not entirely without probléms. As one of this areas, we can mention rare diseases and drugs for treatment of these diseases – so-called

orphan drugs. Last century, during 80´s, this problem became an issue and also some solutions have appeared. The treatment of the

rare disease and orphan drugs development is handled now by adaptation of legal regulations, which offers preferential conditions for

orphan drugs research and development. In 1983, the Regulation fundamental for rare disease treatment has been approved in the US.

Similar procedures and regulations in the Europe, Japan, Australia followed US regulation. At present, orphan drugs development stays

in the forefront of experts, researchers, and politicians looking for funds that allows needful drugs available for patients all around the

world. The article brings the summary of orphan drugs marketed in the Czech Republic.

Keywords: rare diseases, orphan drugs, orphan drugs marketed in the Czech Republic

Published: June 1, 2010  Show citation

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Fričová V, Fričová K. Orphan drugs. Praktické lékárenství. 2010;6(3):139-143.
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References

  1. http://ec.europa.eu/health.
  2. http://www.orpha.net.
  3. Kuželová M, Kubáčková K., ,Orphan" lieky. Klinická farmakologie a farmacie; 2007: 1-3.
  4. http://www.emea.europa.eu.
  5. Mikro-verze AISLP pro autonomní užívání ve zdrav. organizacích, verze 2009.2.
  6. Věstník SÚKL 3/09.




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