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GSK Gel Endorsed by EMA to Prevent Umbilical Cord Infections Outside EU


April 29, 2016.

The European Medicines Agency (EMA) has recommended Umbipro - a reformulation of the antiseptic solution (chlorhexidine) used in GSK's Corsodyl mouthwash - as an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies in countries outside the European Union (EU).   Chlorhexidine works by killing or preventing the growth of bacteria on the skin. It was identified by the United Nations as one of 13 life-saving commodities for women and children that if accessed more widely and properly used, could save the lives of more than six million women and children in the world’s poorest countries.   Umbipro was submitted to EMA under a regulatory procedure (Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low-income countries outside the EU. Article 58 products are assessed by EMA in collaboration with WHO and are required to meet the same standards as medicines intended for EU citizens.   GSK will next submit local regulatory applications for the gel in low-income countries with moderate to high rates of neonatal deaths where supply is needed. If approved, the company will offer the gel at a not-for-profit price. GSK plans to initially manufacture around six million sachets, increasing capacity according to global demand, and the company has said it will share its manufacturing knowledge with other interested companies to enable them to make the gel.        

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