Tamiflu

RSS

oseltamivir

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

Overview

Tamiflu is an antiviral medicine used to treat or prevent influenza (flu).

  • to treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;
  • to prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community. This is generally done on a case-by-case basis. Tamiflu can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu). During a flu pandemic, Tamiflu can also be used to prevent flu in babies below 1 year of age.

Tamiflu cannot replace flu vaccination, and its use should be based on official recommendations.

The medicine contains the active substance oseltamivir.

This EPAR was last updated on 07/02/2019

Authorisation details

Product details
Name
Tamiflu
Agency product number
EMEA/H/C/000402
Active substance
oseltamivir
International non-proprietary name (INN) or common name
oseltamivir
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J05AH02
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
20/06/2002
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

11/01/2019 Tamiflu - EMEA/H/C/000402 - II/0136

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

Therapeutic indication

Treatment of influenza

Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza

  • Post-exposure prevention in individuals one 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 Tamiflu 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.
  • Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak.

Tamiflu is not a substitute for influenza vaccination.

The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating