DECTOVA Solution for infusion Ref.[27672] Active ingredients: Zanamivir

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Dectova 10 mg/mL solution for infusion.

Pharmaceutical Form

Solution for infusion.

A clear, colourless solution for infusion.

Qualitative and quantitative composition

Each mL of solution contains 10 mg of zanamivir (as hydrate).

Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.

Excipients with known effect:

Each vial contains 3.08 mmol (70.8 mg) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zanamivir

Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and promotes virus spread in the respiratory tract. The activity of zanamivir is extracellular. It reduces the propagation of both influenza A and B viruses by inhibiting the release of infectious influenza virions from the epithelial cells of the respiratory tract.

List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.

Pack size: 1 vial.

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/18/1349/001

Date of first authorisation: 26 April 2019

Drugs

Drug Countries
DECTOVA Austria, Estonia, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.