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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

Better medicines for children: challenges and unmet needs

This review deals with the use of medicinal products in children. Many medicinal products administered routinely to paediatric patients have been either not licensed for use in children (unlicensed use) or have been prescribed outside the terms of their product license (off-label prescribing). A lot of surveys have been conducted in the context of identifying the extent of off-label used drugs in children documenting high rates (45-60 %) of such use. Recognising and meeting challenges as development of suitable formulations for very young children and realization of clinical trials involving children present important steps in the enhancement of the present situation. To improve the health of children in Europe, the Regulation (EC) No 1901/2006 addressing the pharmaceutical industry, research teams and member states proposing important incentives and obligations was assigned. Paediatric Investigation Plan and Paediatric Use Marketing Authorisation present the key measures of the EU regulation on medicinal products for paediatric patients.

Orphan drugs used for treatment in pediatric patients in the slovak republic

Due to the enormous success of scientific research in the field of paediatric medicine many once fatal children's diseases can now be cured. Great progress has also been achieved in the rehabilitation of disabilities. However, there is still a big group of diseases defined as rare, treatment of which has been traditionally neglected by the drug companies mainly due to unprofitability.

Since 2000 the treatment of rare diseases has been supported at the European level and in 2007 paediatric legislation was introduced. Both decisions together support treatment of rare diseases in children.

In this paper, we shortly characterise the possibilities of rare diseases treatment in children in the Slovak republic and bring the list of orphan medicine products (OMPs) with defined dosing in paediatrics, which were launched in the Slovak market. We also bring a list of OMPs with defined dosing in children, which are not available in the national market. This incentive may help in further formation of the national plan for treating rare diseases as well as improvement in treatment options and availability of rare disease treatment in children in Slovakia.

References Based on the authors' presentation given at the 20 th Symposium of Clinical Pharmacy in honour of late Assoc. Prof. PharmDr. Lívia Magulová, PhD., Nitra, Slovakia, April 28 - 29, 2011. Regulation (EC) No 1901/2006 of the European Parliament and the Council, as amended, on medicinal products for paediatric use (‘Paediatric Regulation’). Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:EN:PDF ICH E11 Note for Guidance on the Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP

References 1. EMA/428172/2012. European Medicines Agency with its Paediatric Committee. 5-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric Regulation; http://ec.europa.eu/health/files/paediatrics/2012-09_pediatric_report-annex1-2_en.pdf; access date October 28, 2014. 2. F. Brion, A. J. Nunn and A. Rieutord, Extemporaneous (magistral) preparation of oral medicines for children in European hospitals, Acta Paediatr. 92 (2003) 486-490. 3. J. Hempenstall and C. Tuleu, Formulating better