EMA — authorised 26 April 2019
- Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
- Status: approved
🇪🇺 Relenza in European Union
EMA authorised Relenza on 26 April 2019
Marketing authorisations
EMA — authorised 26 April 2019
- Application: EMEA/H/C/004102
- Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
- Local brand name: Dectova
- 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.
- Pathway: exceptional circumstances
- Status: approved
Relenza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Relenza approved in European Union?
Yes. EMA authorised it on 26 April 2019; EMA authorised it on 26 April 2019.
Who is the marketing authorisation holder for Relenza in European Union?
GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.