🇪🇺 OSELTAMIVIR in European Union

EMA authorised OSELTAMIVIR on 22 May 2014

Marketing authorisation

Application: EMEA/H/C/003717
Marketing authorisation holder: Actavis Group PTC ehf
Local brand name: Ebilfumin
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 w
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is OSELTAMIVIR approved in European Union?

Yes. EMA authorised it on 22 May 2014.

Who is the marketing authorisation holder for OSELTAMIVIR in European Union?

Actavis Group PTC ehf holds the EU marketing authorisation.