Dectova

RSS

Zanamivir

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 07/06/2019

Authorisation details

Product details
Name
Dectova
Agency product number
EMEA/H/C/004102
Active substance
Zanamivir
International non-proprietary name (INN) or common name
Zanamivir
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J05AH01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Trading Services Limited
Contact address
Currabinny
Carrigaline
County Cork
Ireland

Product information

26/04/2019 Dectova - EMEA/H/C/004102 -

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

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.

Assessment history

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