Oseltamivir phosphate - EPARs for human use

FICHA FARMACOLÓGICA de Oseltamivir phosphate Contiene la Monografía en distintos idiomas (de la Unión 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. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. FEBRERO 19, 2010.-

abrir aquí para acceder al documento EMEA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/tamiflu/tamiflu.htm

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.

Tamiflu is indicated for the treatment of infants below 12 months of age during a pandemic influenza outbreak (see section 5.2).


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 below 12 months of age during a pandemic influenza outbreak (see section 5.2).

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.



Based on limited pharmacokinetic and safety data, Tamiflu can be used in infants below 12 months of age for treatment during a pandemic influenza outbreak. 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.


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

Orphan medicinal product designation date
Not applicable