This medicine is authorised for use in the European Union.


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 08/10/2021

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
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.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
GlaxoSmithKline Trading Services Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11

Product information

21/09/2021 Dectova - EMEA/H/C/004102 - N/0012

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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