LONDON (Alliance News) - GlaxoSmithKline PLC said Monday that it has submitted a regulatory application to the European Medicines Agency for its antiseptic chlorhexidine digluconate gel for the prevention of umbilical cord infections in newborn babies.
The EMA has granted the application an accelerated assessment, Glaxo said, and as a result intends to provide a scientific opinion on the submission within 150 days.
Glaxo said the gel is intended exclusively for use in developing countries. It will offer it at a not-for-profit price and will share its manufacturing knowledge with others to enable it to be made locally.
Shares in GlaxoSmithKline were down 0.7% at 1,301.50 pence Monday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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Glaxosmithkline (GSK)