Levoplant Receives WHO Prequalification

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On June 30, 2017, the World Health Organization (WHO) prequalified Sino-implant (II), a long-acting 2-rod reversible contraceptive implant marketed globally under the name of Levoplant. This milestone is the culmination of more than a decade of committed collaboration between key partners: Shanghai Dahua Pharmaceutical Co., Ltd.; FHI 360; the Bill & Melinda Gates Foundation; the U.S. Agency for International Development (USAID); distributors including DKT, Marie Stopes International, and Pharm Access Africa Limited; as well as service delivery groups, national governments, and others.

The product has been prequalified by WHO for a 3-year duration of use, with the pivotal trial ongoing into the fourth year; registrations at the national level are currently being updated. In November 2016, the United Nations Population Fund approved Levoplant/Sino-implant (II) for purchase by its country programs through the WHO Expert Review Panel process. WHO prequalification will now allow additional donors to purchase the product for country programs.

More information is available here.

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Categorised in: Contraceptive, Methods, Regulatory

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