11 March 2019 | News
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission
GSK recently 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 paediatric 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 authorisation 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 authorisation is granted by the European Commission. When approved, the intravenous formulation of zanamivir will be known as Dectova.