Medicines for children: The European paediatric initiative

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Publication Date 28/10/2004
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The use of unlicensed and off label medicine in children is widespread and it has been an increasing concern over the last few years. The general lack of information and appropriate pharmaceutical formulations to support the administration of many medicines to children may expose them to unwanted side effects or underdosing without the expected efficacy. The need for more studies to obtain paediatric information for medicines used in children is now a matter of consensus on a global basis.This page on the website of the European Medicines Agency provides background information on the 'European Paediatric Initiative' and includes a link to the current legislative process.
Source Link Link to Main Source http://www.emea.europa.eu/htms/human/peg/pegfaq.htm
Related Links
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/04/1150&format=HTML&aged=0&language=EN&guiLanguage=en http://europa.eu/rapid/pressReleasesAction.do?reference=IP/04/1150&format=HTML&aged=0&language=EN&guiLanguage=en
European Medicines Agency: Proposal for a Regulation of the Council and of the Parliament on Medicinal Products for Paediatric Use: Key documents http://pharmacos.eudra.org/F2/Paediatrics/index.htm
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