GSK receives a positive CHMP opinion for intravenous zanamivir for the treatment of complicated influenza
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for intravenous zanamivir for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and pediatric patients (aged ≥6 months) when the patient’s influenza virus is known or suspected to be resistant to anti-influenza agents other than zanamivir, and/or other anti-viral agents for treatment of influenza, including inhaled zanamivir (Relenza), are not suitable for the individual patient.
The marketing authorization application was submitted under the exceptional circumstances regulatory legislation in the European Union. A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission. When approved, the intravenous formulation of zanamivir will be known as Dectova.
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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2017.
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