GSK submits new application for Synflorix to EMA
GlaxoSmithKline has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval of an additional indication for Synflorix in the European Union (EU). This application is seeking the use of Synflorix as a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptoccuss pneumoniae in infants and children aged between 6 weeks and 5 years.
Synflorix is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptoccuss pneumoniae in infants and children aged between 6 weeks and 5 years. The drug is approved for treatment against pneumonia in 67 of the 90 countries.
Synflorix has not been approved by the FDA for use in the United States and GSK has previously indicated that it may not attempt to sell the vaccine to the US market.
GlaxoSmithKline seeks expanded EU approval of Synflorix for pneumonia (First word pharma)
GlaxoSmithKline Submits New Application for Synflorix in EU (Fox Business)
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