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Home » Press Center » VSI Newsroom » Kenya, Zambia second misoprostol registrations
September 15, 2010

Kenya, Zambia approve additional misoprostol products for life-saving obstetrical use

(NAIROBI, KENYA) -- The drug regulatory agencies of Kenya and Zambia have approved each country’s second misoprostol product to address conditions contributing to preventable maternal death. On August 25, 2010, the Pharmacy and Poisons Board of Kenya approved the registration of a second misoprostol product, Misoclear® tablets, for the life-saving indications of prevention and treatment of postpartum hemorrhage (PPH), treatment of incomplete abortion and miscarriage, treatment of missed abortion, cervical ripening and treatment for intrauterine fetal death. Bringing a second product to market expands availability and drives price competition for this tablet, a key strategy in the country’s efforts to reduce maternal mortality.

Earlier in the month the Pharmaceutical Regulatory Authority of Zambia took the landmark policy step of approving the registration of a 200mcg tablet marketed under the name Misoprost® for prevention and treatment of PPH, treatment of incomplete abortion and miscarriage, treatment of missed abortion, cervical ripening and treatment of intrauterine fetal death.  This is the second misoprostol product registered in the country for PPH, but the first for these additional life-saving uses. A 25mcg tablet was also registered for labor induction.

The registration in Zambia follows closely on the heels of the completed Ministry of Health and VSI pilot testing misoprostol distribution through antenatal care visits for prevention of PPH.  Zambia joins a growing number of African countries who have registered the tablets for these obstetric and gynecologic uses, the sum of which can be seen on VSI’s global registration map.