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.
Tamiflu : EPAR - Medicine overview (PDF/83.1 KB)
First published: 01/12/2009
Last updated: 07/02/2019
Tamiflu : EPAR - Risk-management-plan summary (PDF/93.12 KB)
First published: 07/02/2019
Last updated: 23/04/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
08/04/2020 Tamiflu - EMEA/H/C/000402 - II/0142
- 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.
Antivirals for systemic use
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.
European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection19/11/2013
European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations23/10/2012
European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic08/05/2009