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20JAN2017 (Accessed 20JAN2017). 13. EMA 2015. European Medicines Agency decision CW/0001/2015 of 23 July 2015 on class waivers, in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council. www.ema.europa.eu/docs/en_GB/document_library/Other/2015/07/WC500190385.pdf 14. EMA 2015. Better Medicines for Children. www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2009/12/WC500026493.pdf 15. EMA2016. 10-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric

://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf ERNEST, T. B. - ELDER, D. P. - MARTINI, L. G. - ROBERTS, M. - FORD, J. L.: Developing paediatric medicines: identifying the needs and recognizing the challenges. J Clin Pharm Ther 59, 2007, p. 1043-1055. CONSTABLE, S. - WINSTANLEY, P. - WALLEY, T.: Medical Pharmacology. Third edition, Churchill Livingstone Elsevier 2007, p. 278-279. EMA. Reflection paper: formulation of choice for the paediatric population. 2006. EMEA/CHMP/PEG/194810/2005. FORTWENGEL, G. - OSTERMANN, H. - STAUDINGER, R.: Better medicines for children: Clinical

commentary - Formulating better medicines for children, Int. J. Pharm. 379 (2009) 143-142; DOI: 10.1016/j.ijpharm.2009.06.033. 15. Ora® Products Data Sheets; http://www.perrigo.com/business/prodsearch.aspx?group=paddock; access date October 28, 2014. 16. M. C. Nahata and V. A. Loyd, Extemporaneous drug formulations, Clin. Ther. 30 (2008) 2112-2119; DOI: 10.1016/j.clinthera.2008.11.020. 17. USP/NF 36/31. United States Pharmacopeia 2012, The United States Pharmacopeial Convention 1206, Rockville 2012, pp. 1958; 1964; 2116; 2118; 2262. 18. S. M. El-Gizawy, O. H. Abdelmageed