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EMA Product

Dectova

Product approved by European Medicines Agency (EU)

Basic Information

Dectova

Regulatory Information

EMEA/H/C/004102

Authorised

April 26, 2019

April 26, 2019

6

December 11, 2024

Company Information

Ireland

12 Riverwalk Citywest Business Campus Dublin 24 D24 YK11

GLAXOSMITHKLINE TRADING SERVICES LIMITED

Drug Classification

Additional MonitoringExceptional Circumstances

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Dectova is indicated 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 medicinal products other than zanamivir, and/or - Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance.

Overview Summary

Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age. Complicated influenza is a severe flu infection that requires hospitalisation of the patient. The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient. Dectova contains the active substance zanamivir.

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