EPARs human use - Tamiflu//Oseltamivir phosphate

FICHA FARMACOLÓGICA de Oseltamivir phosphate. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 30, 2009.-

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EPARs for authorised medicinal products for human use - Tamiflu

Active Substance
Oseltamivir phosphate
International Nonproprietary Name or Common Name
Oseltamivir
Pharmaco-therapeutic Group
Neuraminidase inhibitors
ATC Code
J05AH02

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. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A.

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 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 antivirals for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses and the impact of the disease in different geographical areas and patient populations.

Date of issue of Marketing Authorisation valid throughout the European Union
20 June 2002