[MMV][MMV][MMV]
 RSS imprimer Printenvoyer par email Email this page Glossary  

Development Projects

Coartem® Dispersible (artemether and lumefantrine) - Approval/Launch

 

: : : MMV03/3001

Project description:
Novartis and MMV have completed the development of a paediatric dispersible tablet containing a fixed-dose combination of artemether and lumefantrine for the treatment of P falciparum malaria. To mask the bitter taste of the active ingredients, this medicine has a cherry flavour - chosen after studies with African children. The course of treatment is twice-a-day over three days. This product is easy and cost-effective to manufacture and, aside from a few additions to the pictorial instructions to encourage responsible use, will retain the well-known WHO package format currently used by Coartem®.

The regulatory dossier was submitted to Swissmedic in December 2007, based on clinical data comparing the dispersible formulation with the original Coartem®. The drug was approved by Swissmedic in December 2008. In addition to approval by Swissmedic, Coartem Dispersible has also been approved in 14 countries in Africa including Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Ghana, Guinea, Ivory Coast, Kenya, Madagascar, Mali, Mauritania, Niger, Nigeria, Senegal, Togo and Zambia.

The product will be officially launched in these countries in 2009, and we consider it to be the product of choice for children.


News

-  January 2009: Read about the launch of Coartem® Dispersible in Basel, Switzerland and the Pan-African launch which started on 16 February 2009