ARTICLE | Clinical News

Pyramax pyronaridine-artesunate regulatory update

February 27, 2012 8:00 AM UTC

EMA's CHMP issued a positive scientific opinion recommending use of Pyramax fixed-dose pyronaridine/artesunate from Shin Poong to treat acute, uncomplicated malaria infection caused by Plasmodium falciparum or by P. vivax in adults and children >=20 kg as a single 3-day treatment course in areas of low transmission with evidence of artemisinin resistance. The opinion was given under Article 58 of EC Regulation No. 726/2004, which allows CHMP to issue a scientific opinion in cooperation with the World Health Organization (WHO) on the use of medicines intended for ex-EU use for diseases of major public interest. The CHMP opinion can be used as the basis for a marketing application in countries outside of the EU and facilitates the WHO prequalification process. ...