GC Pharma announced today it has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) expanding the indication for GCFLU Quadrivalent™ (Seasonal Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was approved for use in persons 3 years of age and older.
YONGIN, South Korea, Sept. 30, 2018 /PRNewswire/ -- GC Pharma (formerly known as Green Cross) announced today it has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) expanding the indication for GCFLU Quadrivalent™ (Seasonal Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was approved for use in persons 3 years of age and older.
“The flu is a serious diseases with a significant impact on public health, “said Byung-Wha Kim GC Pharma Executive Vice President. “The expanded indication builds upon GC Pharma’s legacy as the first local manufacturer to bring quadrivalent flu vaccines to the South Korean marketplace.”
With this approval, provides are now able to use the GCFLU Quadrivalent™ to vaccinate all eligible persons from 6 months and older.
This expanded indication for the vaccine was based on Phase III clinical studies conducted in children 6 months through 35 months of age.
GCFLU Quadrivalent™ was first approved in 2015 in South Korea for the prevention of influenza disease. It has also received prequalification status from the World Health Organization (WHO).
About Seasonal Influenza
Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalisations.
About GC Pharma
GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, GC Pharma is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company’s registered, legal name.
This release includes forward-looking statements, which express the current beliefs and expectations of GC Pharma’s management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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SOURCE GC Pharma
