|
|
|
|
||
Potential paediatric interest of this medicine suggested by PDCO: fatty acid metabolism disorders, Kawasaki disease, nephrotic syndrome, obesity, and in children who are treated with anti-epilepsy medicines or who received radiation therapy.Looking very promising! Potential paediatric interest of this medicine suggested by PDCO: fatty acid metabolism disorders, Kawasaki disease, nephrotic syndrome, obesity, and in children who are treated with anti-epilepsy medicines or who received radiation therapy. Paediatric Committee (PDCO) Minutes for the meeting on 12-14 August 2015 Class waiver (section 6 Discussion on the applicability of class waiver) As some diseases do not affect children (for example Parkinson's disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and it will be waived. For more information on the classes of diseases subject to waivers, see class waivers. Page 7/20 6. Discussion on the applicability of class waivers 6.1. Discussions on the applicability of class waiver for products 6.1.2. RVX000222 - EMEA-32-2015 Resverlogix Corp; Treatment of coronary atherosclerosis/ Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease and diabetes mellitus, in combination with high potency statins as an adjunct to correction of other risk factors and other cardioprotective therapy Rapporteur: Angeliki Siapkara Summary of committee discussion: The applicability of the class waiver to the planned therapeutic indication was confirmed. Potential paediatric interest of this medicine suggested by PDCO: fatty acid metabolism disorders, Kawasaki disease, nephrotic syndrome, obesity, and in children who are treated with anti-epilepsy medicines or who received radiation therapy. http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2015/09/WC500193815.pdf =============================== Paediatric Committee (PDCO) The Paediatric Committee (PDCO) is the committee at the European Medicines Agency that is responsible for assessing the content of paediatric investigation plans and adopting opinions on them. This includes assessing applications for full or partial waivers and assessing applications for deferrals. The PDCO was established in accordance with the Paediatric Regulation (Regulation (EC) 1901/2006 as amended). See the full overview of the PDCO's role. Composition The PDCO is composed of: five members of the Committee for Medicinal Products for Human Use (CHMP), with their alternates. These members are appointed by the CHMP itself; one member and one alternate appointed by each European Union (EU) Member State that is not represented by the members appointed by the CHMP; three members and alternates representing healthcare professionals; three members and alternates representing patient associations. The members of the PDCO are appointed for a renewable period of three years. The chair is elected from its members. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000265.jsp |
return to message board, top of board |