Dectova (zanamivir)
- Region
- 🇪🇺 EU
- Active substance
- zanamivir
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Fri 26 Apr 2019
- EU approval
- Fri 26 Apr 2019
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/004102
- ATC
- J05AH01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.