Ebilfumin (oseltamivir)
- Region
- 🇪🇺 EU
- Active substance
- oseltamivir
- Company
- Actavis Group PTC ehf
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Thu 22 May 2014
- Designations
- Generic
- Application
- EMEA/H/C/003717
- ATC
- J05AH02
- Official record
- www.ema.europa.eu
Indication
Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tamiflu Authorised · Roche Registration GmbH
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