Tamiflu

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 Tamiflu. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tamiflu.

This EPAR was last updated on 31/08/2018

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
33
Date of issue of marketing authorisation valid throughout the European Union
19/06/2002
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

08/08/2018 Tamiflu - EMEA/H/C/000402 - N/0137

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

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