Ebilfumin

RSS

oseltamivir

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ebilfumin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ebilfumin.

For practical information about using Ebilfumin, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/05/2019

Authorisation details

Product details
Name
Ebilfumin
Agency product number
EMEA/H/C/003717
Active substance
oseltamivir
International non-proprietary name (INN) or common name
oseltamivir
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J05AH02
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
22/05/2014
Contact address
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Product information

11/04/2019 Ebilfumin - EMEA/H/C/003717 - IB/0013

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Antivirals for systemic use

  • Neuraminidase inhibitors

Therapeutic indication

Treatment of influenza
In 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 influenza
Post-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.

Assessment history

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