Primex dient aanvraag marktvergunning in voor pediatrische pijnstiller
ZUG, Zwitserland–(BUSINESS WIRE)– Het Zwitserse bedrijf Primex Pharmaceuticals AG kondigt aan dat het een aanvraag van een marktvergunning (MAA) in de Europese Unie heeft ingediend voor ADV6209 als milde pijnstiller voor kinderen van een halfjaar tot 17 jaar oud. De pijnstiller is bedoeld voor therapeutische of diagnostische procedures, zoals pre-medicatie voorafgaand aan anesthesie.
Primex, dat samenwerkt met Advicenne, heeft de MAA via een decentrale procedure ingediend. De Franse Nationale Autoriteit voor de Veiligheid van Medicijnen en Geneeskundige Producten treedt namens andere betrokken lidstaten op op als referent-lidstaat. De andere betrokken lidstaten zijn onder meer het Verenigd Koninkrijk, Italië, Nederland en Finland.
Primex Files for Marketing Authorization for a paediatric sedative medication |
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ZUG, Switzerland–(BUSINESS WIRE)– Swiss company Primex Pharmaceuticals AG announces it has submitted a Marketing Authorization Application (MAA) in the EU for ADV6209 to be indicated in children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia. Primex, working with its partner Advicenne, has submitted the MAA through a decentralized procedure working with the French National Agency for Medicines and Health Products Safety (ANSM) acting as the reference member state on behalf of other concerned member states, including the UK, Italy, Netherlands and Finland. Mr Alan Knox, Head of Global Marketing comments: “For children, there is a large unmet need for premedication prior to anaesthesia, and a huge unmet need for procedural sedation, such as in emergency and diagnostic procedures”. Primex acquired the global rights for ADV6209 from the French pharmaceutical laboratory Advicenne SA who had collaborated with Amiens University Hospital. Kari Sarvanto, President and Co-Founder of Primex Group, adds: “This is an important step for Primex in the area of paediatric anaesthesia, as the annual market potential should be between 100 million euros and 350 million euros.” Dr Luc-André Granier, CEO of Advicenne, adds: “As one of the very first in-house developed products, this MAA validates our strategy and capabilities in developing original paediatric-adapted drugs.” About Primex Pharmaceuticals, www.primexpharma.com Primex Pharmaceuticals is a fast-growing global specialty company spearheading a new lean pharmaceutical business model with the vision to become the leading global innovative anaesthesia pharmaceutical company. Primex Pharmaceuticals’ global partner network operates in over 40 countries. The company is headquartered in Switzerland. All Primex Pharmaceutical products are manufactured in the EU. Primex Pharmaceuticals has proven underlying business operations and historical strong revenue growth (29% CAGR in 2012–2015). About Advicenne, www.advicenne.com Advicenne, a specialty pharma, focuses on innovative pediatric medications, targeting orphan or neglected diseases within the fields of neurology and nephrology and aims to become a world leader in those therapeutic areas. View source version on businesswire.com: http://www.businesswire.com/news/home/20161005005639/en/ Contacts Primex Pharmaceuticals |
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