Dectova
Zanamivir
Table of contents
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.
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Dectova : EPAR - Medicine overview (PDF/77.69 KB)
First published: 07/06/2019
EMA/161401/2019 -
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Dectova : EPAR - Risk-management-plan summary (PDF/345.2 KB)
First published: 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 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 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 | |
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Marketing-authorisation holder |
GlaxoSmithKline Trading Services Limited
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
26/04/2019
|
Contact address |
12 Riverwalk |
Product information
21/09/2021 Dectova - EMEA/H/C/004102 - N/0012
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.