The developer, GlaxoSmithKline won’t make any profits from the deal, as it partnered with the Save the Children charity to design the gel specifically for developing countries to be sold at a not-for-profit price.
The regulatory win is big for GSK, who is battling critics who are skeptical of the benefits from combining pharmaceuticals with consumer products such as mouthwash.
Researchers developed the product by reformulating chlorhexidine solution from Corsodyl mouthwash into a gel that can be applied to newly cut umbilical cords.
The development was prompted by a U.N. commission report in 2012 that identified chlorhexidine as an overlooked treatment that could save hundreds of thousands of lives a year.
Umbilical cord stumps can act as an entry point for bacteria and life-threatening illness, especially in poorer countries with limited access to healthcare.
The new product will be known as the Umbipro, and will consist of a single-use sachet, and was reviewed under a special procedure that allowed the EMA to evaluate it despite it not being marketed in Europe.
GSK said it has plans to manufacture approximately 6 million sachets, and will increase capacity according to demand. The company will also share the manufacturing details with other companies interested in making the gel.
Material from Reuters was used in this report.